Associate Director Regulatory Affairs CMC (FSP)

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
We are hiring an Associate Director Reg Affairs - CMC for one of our key clients.
This is a position to lead and execute CMC regulatory strategy and submissions for EMEA region. Its major function will be to lead the CMC Regulatory Strategy and submissions for Biologicals:

Responsibilities:

• Lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.
• Serve as the subject matter expert on biologics, providing CMC regulatory guidance for the preparation of regulatory submissions to the EMA and regional agencies.
• Act as the primary liaison for CMC regulatory matters related to biologicals, collaborating with internal teams (R&D, Quality, Manufacturing, Global Regulatory) to align on submission strategies.
• Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAA and variations.
• Coordinate responses to CMC-related questions and deficiencies raised by the EMA or other EMEA health authorities during product registration.

Post-Approval Compliance and Lifecycle Management:

• Perform change control impact assessment for CMC changes
• Lead the CMC regulatory management and submission planning of post-approval changes, including manufacturing process changes, site transfers, and formulation updates for biological products
• Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals.
• Monitor and assess regulatory guidance related to biologics and provide strategic input into regulatory filings.

SKILLS AND COMPETENCIES

• Strong knowledge of EMA regulations, ICH guidelines, and EMEA-specific CMC regulatory requirements for biologics.
• Proven experience leading CMC regulatory submissions for biological products, including initial MAA submissions and post-approval lifecycle management.
• Strong understanding of biologics manufacturing, characterization, comparability, and analytical testing requirements.
• Excellent project management skills with the ability to manage complex projects and timelines.
• Strong communication and interpersonal skills, with experience working in cross-functional and international teams.
• Fluent in English – working language.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Master degree or PhD in biotechnology, pharmaceutical sciences or bio‐engineering, with relevant expertise in CMC development and CMC regulatory for biological products (min 10 yrs)

• Lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.
• Serve as the subject matter expert on biologics, providing CMC regulatory guidance for the preparation of regulatory submissions to the EMA and regional agencies.
• Act as the primary liaison for CMC regulatory matters related to biologicals, collaborating with internal teams (R&D, Quality, Manufacturing, Global Regulatory) to align on submission strategies.
• Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAA and variations.
• Coordinate responses to CMC-related questions and deficiencies raised by the EMA or other EMEA health authorities during product registration