Naar de inhoud

Global trade compliance lead Vacatures

Vind je nieuwe baan tussen 12 global trade compliance lead vacatures

Laat de perfecte global trade compliance lead vacatures niet aan je voorbijgaan

Je kunt de zoekalert beheren vanuit de mail

Global Trade Compliance Manager

bij Signify in Eindhoven - Noord-Brabant
op website van werkgever
Geplaatst op:
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you will lead Signify's global trade compliance strategy from Eindhoven, shaping policies and governance across export controls, sanctions, customs and dangerous goods. You'll build and guide a small expert team, drive regulatory alignment, and enable business impact through policy, training and process improvement. You'll participate in technology transformation, including S/4HANA and AI-enabled capabilities, to sustain compliant operations at scale. This is a high-impact, cross-functional leadership opportunity in a purpose-driven company.

Verantwoordelijkheden

  • Define and lead global trade compliance strategy, governance, policies and standards covering export controls, customs, sanctions and dangerous goods
  • Establish and ensure consistent global processes, systems and control frameworks across regions and businesses
  • Lead and develop the Global Trade Compliance organization, including program managers and dangerous goods manager
  • Monitor regulatory developments and adapt policies and processes accordingly
  • Oversee the trade compliance program, including training, awareness, monitoring and continuous improvement
  • Advise senior leadership on regulatory risks and strategic decisions as global SME
  • Collaborate with cross-functional teams to align governance with business needs

Belangrijkste vereisten

  • 10+ years of experience in trade compliance, customs, export controls, sanctions, dangerous goods or related fields

  • Experience in a multinational environment, ideally in manufacturing, electronics, lighting or regulated products

  • Strong knowledge of export controls, sanctions, classification, origin, valuation, licensing and dangerous goods

  • Designed or improved compliance frameworks, policies and training across multiple countries/regions

  • Proven people leadership in a small expert team

  • Ability to influence in a matrix organization and align regional and functional teams

  • Ability to translate regulatory topics into clear business recommendations and practical improvements

  • Experience with ERP/trade compliance systems (SAP, SAP GTS, S/4HANA) and data analytics/AI-enabled compliance

  • Stakeholder management

  • Strategic thinking

  • Cross-functional collaboration

  • SAP

  • SAP GTS

  • S/4HANA

Direct solliciteren
solliciteer op website van werkgever

Customs Compliance Specialist

bij Nutreco in Tilburg - Noord-Brabant
op website van werkgever
Dienstverband
Fulltime
Werklocatie
Kantoor
Opleiding
Overig
Ervaring
Ervaren
Functiegroep
Juridisch & Wetgeving

Over de vacature

Overview

In this role you own and shape the customs and trade compliance framework for Global Supply Points, unifying activities across functions into a cohesive approach. You act as the central SME, designing governance, policies and standards for customs, export control and trade compliance, and embedding them into planning, logistics, procurement and export operations. You will lead HS classification, origin determination and compliance controls to strengthen risk management and enable compliant, efficient international trade across manufacturing sites. This position offers a chance to build global customs capability within a dynamic, international setting, contributing to the company's mission to

Arbeidsvoorwaarden / Benefits

  • Competitive salary
  • pension scheme
  • 30 vacation days
  • Opportunities for growth within Nutreco and the SHV group
  • Access to customs and trade training

Verantwoordelijkheden

  • Own and shape the customs compliance framework for Global Supply Points
  • Design and implement governance, policies and standards for customs, export control and trade compliance
  • Embed governance into daily planning, logistics, procurement and export operations
  • Lead HS classification, origin determination and compliance controls
  • Strengthen risk management and enable compliant international trade across locations

Belangrijkste vereisten

  • Strong hands-on experience in customs, export or trade compliance (HS classification, origin, valuation)

  • Experience with customs trade tools and ERP systems in regulated environments

  • Structured, analytical communicator with stakeholder and project management skills

  • Proactive partner capable of independent work and cross-functional collaboration

  • Structured thinking

  • Analytical communication

  • Stakeholder management

  • HS classification

  • Origin determination

  • Valuation

Direct solliciteren
solliciteer op website van werkgever

Director, Trade Compliance - Teledyne Imaging

bij Teledyne AnaFocus in Eindhoven - Noord-Brabant
op website van werkgever
Geplaatst op:
Dienstverband
Fulltime
Werklocatie
Kantoor
Opleiding
WO
Functiegroep
Juridisch & Wetgeving

Over de vacature

Overview

As Director of Trade Compliance, you will lead the global trade compliance program for Teledyne Imaging, partnering with executive leadership to implement policies and drive compliant business operations. You will guide regulatory interpretation across Europe, the U.S., and Canada, while mentoring a team of compliance professionals. This role sits at the intersection of business growth and regulatory risk, shaping processes that enable fast, compliant transactions. You will champion a strategic approach to compliance that adds value to the enterprise and supports cross-functional collaboration.

Verantwoordelijkheden

  • Enhance and maintain trade compliance systems, policies, and procedures
  • Provide guidance on European, U.S., and Canadian regulatory requirements
  • Oversee export compliance including licensing, sanctions, classification, and recordkeeping
  • Train and supervise export compliance personnel across designated Teledyne businesses
  • Communicate with business leaders to balance compliance with operations
  • Inform leadership of regulatory changes impacting trade compliance
  • Implement standardized training aligned with corporate program requirements
  • Coordinate with CITC on inquiries, investigations, and disclosures
  • Identify risks, develop KPIs, and monitor the health of trade activities
  • Manage audits, investigations, root-cause analyses, and continuous program improvement
  • Serve as liaison between operations and trade compliance functions
  • Coordinate across sites to establish unified best practices
  • Lead trade compliance process improvement initiatives
  • Perform other duties as assigned by the Chief Trade Compliance Counsel

Belangrijkste vereisten

  • University bachelor's degree, advanced degree preferred

  • Experience in aerospace, electro-optical/IR tech, semiconductor or related high-tech industries

  • Ability to review jurisdiction/classification, contracts, and licensing while embedding compliance

  • Expertise in European dual-use and military controls; familiarity with ITAR, EAR, OFAC, Canadian laws, and Multilateral Control Regimes

  • Proven leadership and mentoring of trade compliance teams

  • Strong management and program management skills with cross-functional collaboration

  • Ability to work under pressure and make timely business decisions

  • Independent work capability with minimal supervision

  • Strong time management and organizational skills; integrity and professionalism

  • Excellent verbal and written communication and presentation skills

  • Proficiency in Microsoft Office; experience with SAP, OCR, GTS, and Conga

  • Knowledge of customs laws is a plus

  • Willingness to travel up to 25% domestically and internationally

  • Eligible to obtain export control licenses from U.S. authorities

  • leadership

  • communication

  • cross-functional collaboration

  • export control regulations (ITAR, EAR, OFAC)

  • classification and licensing

  • audits and investigations

Direct solliciteren
solliciteer op website van werkgever

Export Compliance Specialist (on-site)

bij Delta Electronics in Amsterdam - Noord-Holland
op website van werkgever
Geplaatst op:
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you will lead Delta's Export Compliance Program for EMEA, ensuring alignment with EU export regulations and corporate policies from Taiwan. You will drive cross-functional collaboration with Sales, Logistics, Legal, and Corporate Governance to embed robust compliance. You'll implement policies, conduct due diligence, and manage regulatory training to mitigate risk across global trade operations. This position offers a chance to shape Delta's compliance posture at scale and work closely with international teams. You will be the go-to expert for export controls, audits, and regulatory changes, delivering transparent, traceable compliance outcomes.

Verantwoordelijkheden

  • Develop, implement, and manage the Export Compliance Program in EMEA
  • Ensure alignment with EU export regulations and Delta Corporate policies from Taiwan
  • Define and maintain Export Compliance policies, procedures, and best practices
  • Lead cross-functional compliance platforms, collaborating with Sales, Logistics, Legal, and Corporate Governance teams
  • Conduct training programs to educate employees on compliance responsibilities and regulatory changes
  • Oversee and execute due diligence checks on customers, suppliers, and third parties
  • Investigate and report compliance violations with corrective actions
  • Monitor regulatory developments and adapt compliance strategies
  • Represent Delta EMEA in export control audits and external regulatory engagements
  • Maintain detailed compliance records and reports, ensuring transparency and traceability

Belangrijkste vereisten

  • 5+ years of experience in export compliance within an international business environment

  • Bachelor's or Master's degree in Law, International Trade, Business, or a related field

  • In-depth knowledge of EU export control regulations (e.g., EU Dual-Use Regulation, UK Export Control Act)

  • Experience in working with government export authorities and compliance frameworks

  • Ability to collaborate with global teams

  • Strong analytical, investigative, and problem-solving skills

  • Excellent communication skills in English; knowledge of another European language or Chinese is a plus

  • Detail-oriented, proactive, and able to manage multiple compliance initiatives simultaneously

  • strong analytical thinking

  • excellent communication

  • cross-functional collaboration

  • EU export control regulations

  • export compliance programs

  • due diligence

Direct solliciteren
solliciteer op website van werkgever

GLO Customs & Compliance Expert

bij Hewlett Packard Enterprise in Amsterdam - Noord-Holland
op website van werkgever
Dienstverband
Overig
Werklocatie
Flex
Opleiding
Overig
Ervaring
Ervaren

Over de vacature

Overview

In this role you will apply your customs and trade knowledge to solve complex import/export problems within established guidelines, supporting regional and global operations. You will collaborate with cross-functional teams, manage broker activities, and advise on regulatory changes to keep trade compliant. The position offers exposure to regional advocacy, emerging markets, and process improvement initiatives that drive efficient, compliant global trade. This is a hands-on role with leadership responsibilities in a fast-evolving regulatory environment.

Arbeidsvoorwaarden / Benefits

  • Health & wellbeing benefits
  • Career development programs
  • Unconditional inclusion and flexibility
  • Global exposure
  • Hybrid work model

Verantwoordelijkheden

  • Ensure compliance with complex trade regulations at country/regional/global levels
  • Manage customs broker activities and align with regional TAT and broker manuals
  • Support Regional Customs Broker Strategy and broker assessments
  • Provide audit support and engage with government authorities as needed
  • Lead regional advocacy with authorities and support emerging markets initiatives
  • Identify opportunities for process improvement in Customs Operations and propose solutions
  • Communicate requirements and guidelines to regional/global teams

Belangrijkste vereisten

  • Understanding of EMEA/Country/International trade regulations in a dynamic environment

  • Customs broker management experience including setting TAT and monitoring performance

  • Experience conducting broker assessments and audits with government authorities

  • Experience responding to routine inquiries from government authorities

  • Strong understanding of supply chain trading flows

  • Excellent written and verbal communication, English and local language; influencing skills

  • Strong analytical skills and project management

  • Leadership skills and ability to work across multiple countries and functions

  • Experience in aligning customs/trade with business objectives

  • Strong communication and influencing abilities

  • Leadership and team-building

  • Cross-functional collaboration

  • Analytical mindset

  • Adaptability to regulatory changes

  • Advanced MS Office

Direct solliciteren
solliciteer op website van werkgever

Export Compliance Specialist (on-site)

bij Delta Electronics in Hoofddorp - Noord-Holland
op website van werkgever
Geplaatst op:
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Consultancy & Advies

Over de vacature

Overview

In this role you will lead Delta's Export Compliance Program for EMEA, ensuring alignment with EU export regulations and corporate policies from Taiwan. You will drive cross-functional collaboration with Sales, Logistics, Legal, and Corporate Governance to embed robust compliance. You'll implement policies, conduct due diligence, and manage regulatory training to mitigate risk across global trade operations. This position offers a chance to shape Delta's compliance posture at scale and work closely with international teams. You will be the go-to expert for export controls, audits, and regulatory changes, delivering transparent, traceable compliance outcomes.

Verantwoordelijkheden

  • Develop, implement, and manage the Export Compliance Program in EMEA
  • Ensure alignment with EU export regulations and Delta Corporate policies from Taiwan
  • Define and maintain Export Compliance policies, procedures, and best practices
  • Lead cross-functional compliance platforms, collaborating with Sales, Logistics, Legal, and Corporate Governance teams
  • Conduct training programs to educate employees on compliance responsibilities and regulatory changes
  • Oversee and execute due diligence checks on customers, suppliers, and third parties
  • Investigate and report compliance violations with corrective actions
  • Monitor regulatory developments and adapt compliance strategies
  • Represent Delta EMEA in export control audits and external regulatory engagements
  • Maintain detailed compliance records and reports, ensuring transparency and traceability

Belangrijkste vereisten

  • 5+ years of experience in export compliance within an international business environment

  • Bachelor's or Master's degree in Law, International Trade, Business, or a related field

  • In-depth knowledge of EU export control regulations (e.g., EU Dual-Use Regulation, UK Export Control Act)

  • Experience in working with government export authorities and compliance frameworks

  • Ability to collaborate with global teams

  • Strong analytical, investigative, and problem-solving skills

  • Excellent communication skills in English; knowledge of another European language or Chinese is a plus

  • Detail-oriented, proactive, and able to manage multiple compliance initiatives simultaneously

  • strong analytical thinking

  • excellent communication

  • cross-functional collaboration

  • EU export control regulations

  • export compliance programs

  • due diligence

Direct solliciteren
solliciteer op website van werkgever

GLO Customs & Compliance Expert

bij Hewlett Packard Enterprise in Amstelveen - Noord-Holland
op website van werkgever
Dienstverband
Overig
Werklocatie
Flex
Opleiding
Overig
Ervaring
Ervaren

Over de vacature

Overview

In this role you will apply your customs and trade knowledge to solve complex import/export problems within established guidelines, supporting regional and global operations. You will collaborate with cross-functional teams, manage broker activities, and advise on regulatory changes to keep trade compliant. The position offers exposure to regional advocacy, emerging markets, and process improvement initiatives that drive efficient, compliant global trade. This is a hands-on role with leadership responsibilities in a fast-evolving regulatory environment.

Arbeidsvoorwaarden / Benefits

  • Health & wellbeing benefits
  • Career development programs
  • Unconditional inclusion and flexibility
  • Global exposure
  • Hybrid work model

Verantwoordelijkheden

  • Ensure compliance with complex trade regulations at country/regional/global levels
  • Manage customs broker activities and align with regional TAT and broker manuals
  • Support Regional Customs Broker Strategy and broker assessments
  • Provide audit support and engage with government authorities as needed
  • Lead regional advocacy with authorities and support emerging markets initiatives
  • Identify opportunities for process improvement in Customs Operations and propose solutions
  • Communicate requirements and guidelines to regional/global teams

Belangrijkste vereisten

  • Understanding of EMEA/Country/International trade regulations in a dynamic environment

  • Customs broker management experience including setting TAT and monitoring performance

  • Experience conducting broker assessments and audits with government authorities

  • Experience responding to routine inquiries from government authorities

  • Strong understanding of supply chain trading flows

  • Excellent written and verbal communication, English and local language; influencing skills

  • Strong analytical skills and project management

  • Leadership skills and ability to work across multiple countries and functions

  • Experience in aligning customs/trade with business objectives

  • Strong communication and influencing abilities

  • Leadership and team-building

  • Cross-functional collaboration

  • Analytical mindset

  • Adaptability to regulatory changes

  • Advanced MS Office

Direct solliciteren
solliciteer op website van werkgever

Legal Counsel Netherlands

bij ABB in Rotterdam - Zuid-Holland
op website van werkgever
Geplaatst op:
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Juridisch & Wetgeving

Over de vacature

Overview

In this role you will provide pragmatic, business oriented legal counsel to ABB's Smart Buildings Division in the Netherlands, partnering with commercial teams to manage risk and uphold integrity. You will support contracts, tenders, and complex transactions while aligning with local laws and global policies. You'll lead risk assessments, oversee disputes, and contribute to labor, data security, and AI/trade compliance matters. This position offers cross functional collaboration in a dynamic, international environment with a clear focus on sustainable, responsible business.

Arbeidsvoorwaarden / Benefits

  • 13th month
  • 27 holiday days and 13 ADV days
  • pension plan
  • opportunities to work from home
  • employee share acquisition program
  • daily fresh fruit at the office

Verantwoordelijkheden

  • Provide legal advice as a business partner to risk assess and support commercial decisions
  • Review and negotiate contracts and commercial terms with stakeholders
  • Assist in risk assessments, public tenders, and projects (notably datacenter)
  • Support M&A/divestitures including structuring, drafting, and negotiation
  • Implement ABB policies locally and promote training on integrity and compliance
  • Assess integrity risks and implement TPM based mitigation strategies
  • Manage litigations/arbitrations and coordinate with external counsel
  • Advise on labor and employment matters and ensure compliance with local labor laws
  • Maintain expertise on digital agreements/SaaS, cyber security, AI, and trade compliance
  • Support strategic local business matters and anticipate future opportunities and challenges
  • Oversee implementation of risk controls and provide proactive dispute avoidance strategies

Belangrijkste vereisten

  • 6-8 years PQE

  • LLM degree in the Netherlands

  • Hands on, cross functional partnership mindset

  • Strong advocacy and negotiation skills; clear written and oral communication

  • Integrity and professionalism with a drive for excellence

  • Ability to operate in a complex international environment and respect diverse cultures

  • Fluent Dutch; professional English proficiency

  • Law firm experience and engineering/industrial sector exposure are desirable

  • cross functional collaboration

  • practical negotiation

  • clear written and verbal communication

  • digital agreements and SaaS

  • cyber security

  • AI and trade compliance

Direct solliciteren
solliciteer op website van werkgever

Legal Counsel Netherlands

bij ABB in Ede - Gelderland
op website van werkgever
Geplaatst op:
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO
Ervaring
Ervaren
Functiegroep
Juridisch & Wetgeving

Over de vacature

Overview

In this role you will provide pragmatic, business oriented legal counsel to ABB's Smart Buildings Division in the Netherlands, partnering with commercial teams to manage risk and uphold integrity. You will support contracts, tenders, and complex transactions while aligning with local laws and global policies. You'll lead risk assessments, oversee disputes, and contribute to labor, data security, and AI/trade compliance matters. This position offers cross functional collaboration in a dynamic, international environment with a clear focus on sustainable, responsible business.

Arbeidsvoorwaarden / Benefits

  • 13th month
  • 27 holiday days and 13 ADV days
  • pension plan
  • opportunities to work from home
  • employee share acquisition program
  • daily fresh fruit at the office

Verantwoordelijkheden

  • Provide legal advice as a business partner to risk assess and support commercial decisions
  • Review and negotiate contracts and commercial terms with stakeholders
  • Assist in risk assessments, public tenders, and projects (notably datacenter)
  • Support M&A/divestitures including structuring, drafting, and negotiation
  • Implement ABB policies locally and promote training on integrity and compliance
  • Assess integrity risks and implement TPM based mitigation strategies
  • Manage litigations/arbitrations and coordinate with external counsel
  • Advise on labor and employment matters and ensure compliance with local labor laws
  • Maintain expertise on digital agreements/SaaS, cyber security, AI, and trade compliance
  • Support strategic local business matters and anticipate future opportunities and challenges
  • Oversee implementation of risk controls and provide proactive dispute avoidance strategies

Belangrijkste vereisten

  • 6-8 years PQE

  • LLM degree in the Netherlands

  • Hands on, cross functional partnership mindset

  • Strong advocacy and negotiation skills; clear written and oral communication

  • Integrity and professionalism with a drive for excellence

  • Ability to operate in a complex international environment and respect diverse cultures

  • Fluent Dutch; professional English proficiency

  • Law firm experience and engineering/industrial sector exposure are desirable

  • cross functional collaboration

  • practical negotiation

  • clear written and verbal communication

  • digital agreements and SaaS

  • cyber security

  • AI and trade compliance

Direct solliciteren
solliciteer op website van werkgever

Trade Services Specialist

bij eFinancialCareers in Amsterdam - Noord-Holland
op website van werkgever
Geplaatst op:
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
HBO
Ervaring
Ervaren

Over de vacature

Overview

A leading international banking institution is seeking a Middle Officer Trade Services professional to support its Global Transaction Banking (GTB) operations in Amsterdam.

The GTB division covers payment and cash management, clearing services, trade finance, factoring, and FX solutions. Trade Services plays a key role in facilitating international trade flows across multiple regions including Europe, Africa, Asia, and the Americas.

Role Context

You will be part of a Netherlands & Belgium Trade Middle Office hub , working closely with teams in Amsterdam and Brussels. This setup ensures strong collaboration, business continuity, and consistent service delivery across the region.

You will interact with multiple stakeholders, including Front Office, Back Office, Risk, Product teams, and international headquarters.

Key Responsibilities

  1. Support Trade Sales in executing trade finance transactions
  2. Manage and follow up on client requests and identify commercial opportunities
  3. Coordinate with Back Office for transaction processing and issue resolution
  4. Collaborate with international teams across the Trade Services network
  5. Handle administrative processes (e.g. invoicing, internal & regulatory reporting)
  6. Perform compliance checks and ensure transactions meet regulatory requirements
  7. Maintain RMA keys for correspondent banking relationships
  8. Verify credit line availability prior to execution of transactions
  9. Monitor credit facilities and validation processes
  10. Contribute to ongoing supervision and control activities
  11. Support cross-selling opportunities across transaction banking products

Products Covered

  1. International Guarantees
  2. Import Letters of Credit
  3. Export Letters of Credit
  4. Cross-selling solutions (e.g. cash management, factoring)

Candidate Profile Education & Experience

  1. HBO Bachelor's degree (or equivalent)
  2. Minimum 3 years' experience within Trade Finance / Transaction Banking

Languages (mandatory) Either Dutch or French Fluency required.

  1. Dutch: C1
  2. English: C1
  3. French: C1

Technical & Operational Skills

  1. Strong knowledge of trade finance products (L/Cs, guarantees)
  2. Solid understanding of banking operations and regulatory frameworks
  3. Proficiency in Microsoft Office (Excel, PowerPoint, Word)
  4. Strong analytical and quantitative capabilities

Soft Skills

  1. Strong client-service mindset
  2. Proactive and able to work both independently and within a team
  3. Excellent stakeholder management skills
  4. Strong organizational and multitasking abilities
  5. Clear communicator, both written and verbal
  6. High level of integrity and professionalism

What Makes This Role Interesting

This is a classic middle office trade finance role with real cross-border exposure , sitting right between commercial activity and operational execution. It offers strong stakeholder interaction and visibility across multiple banking functions-ideal for someone looking to deepen their expertise within Transaction Banking while maintaining a client-facing edge.

Direct solliciteren
solliciteer op website van werkgever

Manager, Regulatory Affairs CMC with Viral Vector experience

bij Kite Pharma in Amsterdam - Noord-Holland
op website van werkgever
Geplaatst op:
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO

Over de vacature

Overview

As Regulatory Affairs CMC Lead, you drive high-quality regulatory CMC deliverables for cell therapy programs and shape global strategies. You partner with cross-functional teams to align development, lifecycle management, and commercialization with regional requirements. You'll interpret EMA/EU/ATMP guidance and influence regulatory decisions while maintaining timelines and operational feasibility. This role sits at the core of advancing cutting-edge cancer therapies and shaping our regulatory posture across programs.

Verantwoordelijkheden

  • Lead regulatory CMC deliverables for clinical and commercial cell therapy programs
  • Develop and execute CMC regulatory strategies aligned with product development stage and regions
  • Author/review regulatory CMC documents ensuring accuracy and compliance
  • Provide CMC guidance to cross-functional teams for development, lifecycle management, and commercialization
  • Interpret EMA/EU/Ph. Eur. and RoW requirements with ATMP expertise
  • Align cross-functional perspectives into a coherent CMC regulatory position
  • Assess CMC change controls for regulatory impact
  • Maintain regulatory IT systems with accurate submission tracking
  • Participate in industry trade groups and associations
  • Update the organization on major international CMC regulatory guidance
  • Leverage industry networks to disseminate CMC best practices
  • Assist in drafting background packages for Health Authority meetings and basic strategies
  • Form ad hoc task forces to address critical CMC issues

Belangrijkste vereisten

  • 8+ years in Regulatory Affairs or relevant industry experience post-Bachelor's

  • Experience with viral vectors and/or lipid nanoparticles

  • Advanced degrees (PhD or MS) desired

  • Sound understanding of ICH and regional regulatory requirements for assigned territories

  • Ability to drive cross-functional deliverables and influence without direct authority

  • Strong written/verbal English; Dutch language is a plus

  • Attention to detail and strong organizational skills

  • Comfortable in a fast-paced environment with changing priorities

  • cross-functional collaboration

  • influencing without authority

  • clear scientific and regulatory writing

  • CMC regulatory strategy development

  • EMA/EU/ATMP regulatory knowledge

  • Regulatory change control assessment

Direct solliciteren
solliciteer op website van werkgever

Manager, Regulatory Affairs CMC with Viral Vector experience

bij Kite Pharma in Hoofddorp - Noord-Holland
op website van werkgever
Geplaatst op:
Dienstverband
Overig
Werklocatie
Kantoor
Opleiding
WO

Over de vacature

Overview

As Regulatory Affairs CMC Lead, you drive high-quality regulatory CMC deliverables for cell therapy programs and shape global strategies. You partner with cross-functional teams to align development, lifecycle management, and commercialization with regional requirements. You'll interpret EMA/EU/ATMP guidance and influence regulatory decisions while maintaining timelines and operational feasibility. This role sits at the core of advancing cutting-edge cancer therapies and shaping our regulatory posture across programs.

Verantwoordelijkheden

  • Lead regulatory CMC deliverables for clinical and commercial cell therapy programs
  • Develop and execute CMC regulatory strategies aligned with product development stage and regions
  • Author/review regulatory CMC documents ensuring accuracy and compliance
  • Provide CMC guidance to cross-functional teams for development, lifecycle management, and commercialization
  • Interpret EMA/EU/Ph. Eur. and RoW requirements with ATMP expertise
  • Align cross-functional perspectives into a coherent CMC regulatory position
  • Assess CMC change controls for regulatory impact
  • Maintain regulatory IT systems with accurate submission tracking
  • Participate in industry trade groups and associations
  • Update the organization on major international CMC regulatory guidance
  • Leverage industry networks to disseminate CMC best practices
  • Assist in drafting background packages for Health Authority meetings and basic strategies
  • Form ad hoc task forces to address critical CMC issues

Belangrijkste vereisten

  • 8+ years in Regulatory Affairs or relevant industry experience post-Bachelor's

  • Experience with viral vectors and/or lipid nanoparticles

  • Advanced degrees (PhD or MS) desired

  • Sound understanding of ICH and regional regulatory requirements for assigned territories

  • Ability to drive cross-functional deliverables and influence without direct authority

  • Strong written/verbal English; Dutch language is a plus

  • Attention to detail and strong organizational skills

  • Comfortable in a fast-paced environment with changing priorities

  • cross-functional collaboration

  • influencing without authority

  • clear scientific and regulatory writing

  • CMC regulatory strategy development

  • EMA/EU/ATMP regulatory knowledge

  • Regulatory change control assessment

Direct solliciteren
solliciteer op website van werkgever