Regulatory affairs cmc lead Vacatures

Over de vacature

Overview

In this Regulatory Affairs CMC Lead role, you will guide regulatory CMC strategy for Kite's cell therapy programs to ensure compliant, timely submissions. You will partner with cross-functional teams to align development plans with regional requirements and program objectives, shaping how therapies reach patients. You'll translate complex CMC considerations into practical guidance, and keep internal systems and stakeholders updated with the evolving regulatory landscape. This is a high-impact role at the forefront of cancer immunotherapies.

Verantwoordelijkheden

• Lead regulatory CMC strategy for assigned cell therapy programs across clinical and commercial stages
• Draft, review, and ensure accuracy of CMC regulatory documentation
• Provide CMC regulatory guidance to cross-functional teams supporting development, lifecycle management, and commercialization
• Interpret EMA, EU, Ph. Eur., and RoW requirements with emphasis on ATMP expectations
• Align cross-functional perspectives into a coherent CMC strategy balancing compliance and timelines
• Assess CMC change controls for regulatory impact across programs
• Maintain accuracy of regulatory IT systems tracking submissions, status, and commitments
• Engage in industry groups and disseminate CMC best practices internally
• Update the corporation on major international CMC regulatory guidance
• Form ad hoc task forces to address critical CMC issues
• Draft background packages for Health Authority meetings and contribute to basic strategies
• Lead initiatives and communicate regulatory updates to stakeholders

Belangrijkste vereisten

• 8+ years in Regulatory Affairs or relevant industry experience after a Bachelor's Degree

• Experience with viral vectors and/or lipid nanoparticles

• Sound understanding of ICH and regional regulatory requirements, with knowledge of global trends in Regulatory Affairs CMC

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

• Strong written and verbal English communication; Dutch proficiency a plus

• Excellent organizational skills, attention to detail, and ownership mindset

• Ability to operate in a fast-paced environment with shifting priorities

• Experience with regulatory IT systems and submissions tracking

• Experience with Health Authority interactions and basic strategy development

• Proficiency with industry-standard software tools

• cross-functional collaboration

• influence without authority

• clear scientific and regulatory communication

• CMC regulatory strategy

• EMA/EU/Ph Eur/RoW regulation interpretation

• ATMP regulatory expectations

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

Over de vacature

Overview

In this Regulatory Affairs CMC Lead role, you will guide regulatory CMC strategy for Kite's cell therapy programs to ensure compliant, timely submissions. You will partner with cross-functional teams to align development plans with regional requirements and program objectives, shaping how therapies reach patients. You'll translate complex CMC considerations into practical guidance, and keep internal systems and stakeholders updated with the evolving regulatory landscape. This is a high-impact role at the forefront of cancer immunotherapies.

Verantwoordelijkheden

• Lead regulatory CMC strategy for assigned cell therapy programs across clinical and commercial stages
• Draft, review, and ensure accuracy of CMC regulatory documentation
• Provide CMC regulatory guidance to cross-functional teams supporting development, lifecycle management, and commercialization
• Interpret EMA, EU, Ph. Eur., and RoW requirements with emphasis on ATMP expectations
• Align cross-functional perspectives into a coherent CMC strategy balancing compliance and timelines
• Assess CMC change controls for regulatory impact across programs
• Maintain accuracy of regulatory IT systems tracking submissions, status, and commitments
• Engage in industry groups and disseminate CMC best practices internally
• Update the corporation on major international CMC regulatory guidance
• Form ad hoc task forces to address critical CMC issues
• Draft background packages for Health Authority meetings and contribute to basic strategies
• Lead initiatives and communicate regulatory updates to stakeholders

Belangrijkste vereisten

• 8+ years in Regulatory Affairs or relevant industry experience after a Bachelor's Degree

• Experience with viral vectors and/or lipid nanoparticles

• Sound understanding of ICH and regional regulatory requirements, with knowledge of global trends in Regulatory Affairs CMC

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

• Strong written and verbal English communication; Dutch proficiency a plus

• Excellent organizational skills, attention to detail, and ownership mindset

• Ability to operate in a fast-paced environment with shifting priorities

• Experience with regulatory IT systems and submissions tracking

• Experience with Health Authority interactions and basic strategy development

• Proficiency with industry-standard software tools

• cross-functional collaboration

• influence without authority

• clear scientific and regulatory communication

• CMC regulatory strategy

• EMA/EU/Ph Eur/RoW regulation interpretation

• ATMP regulatory expectations

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