Description
As a Regulatory Affairs Manager in Chemistry, Manufacturing, and Controls (CMC) for mRNA-based vaccine development products, you will lead key regulatory activities that guide products from late-stage development through early lifecycle management.
In close partnership and collaboration with cross-functional teams including regulatory, manufacturing, quality, and development, you will help shape regulatory CMC strategies that ensure compliance and timely approvals.
Responsibilities:
- Development and execution of CMC (Module 3/2.3) regulatory strategies for vaccine products, ensuring alignment with U.S. regulatory expectations and global requirements (mainly Europe and Japan), including health authority interactions
- Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA/JNDA and early life cycle variations) and consultations to meet regulatory compliance and quality standards.
- Collaborate with and provide timely regulatory advice to cross-functional CMC workstreams and matrix teams including manufacturing and quality to support RA CMC strategy development and flawless execution
- Contribute to planning and tracking of CMC source documents and dossier sections to ensure Right-First-Time submission readiness.
- Identify regulatory risks and propose mitigation plans to ensure smooth project progress and successful submissions.
- Support team members, fostering continuous improvement and sharing best practices in CMC regulatory affairs.
Basic Qualifications & Skills:
- A minimum of a Bachelor’s degree in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline.
- Minimum of 2 years of experience in CMC regulatory affairs, with exposure to vaccine or biologics development and regulatory submissions.
- Minimum of 1 year of experience preparing or contributing to CMC sections of regulatory submissions in the US and EU markets for biologicals and/or vaccines.
Preferred Qualifications & Skills:
- Advanced degree (Master’s or PhD) in a scientific or regulatory field.
- Knowledge of U.S. and global regulatory requirements including FDA regulations, Good Manufacturing Practices (GMP), and guideline standards (e.g. ICH) for biologicals/vaccines.
- Experience working collaboratively within cross-functional teams across regulatory, manufacturing, quality, and development functions.
- Good awareness of AI tools and eagerness to apply them responsibly to increase efficiency and/or quality of RA deliverables.
- Experience with the preparation of regulatory interactions and negotiations including FDA meetings (e.g. Type C or pre-BLA), CHMP Scientific advice and /or PMDA consultations.
- Proven ability to develop and implement CMC strategies for complex vaccine or biologics products while managing multiple priorities and deadlines in a dynamic environment.
- Familiarity with electronic submission formats and systems (e.g. Veeva)
- Experience supporting regulatory inspections and providing input on manufacturing or process changes.
Benefits:
- Competitive salary
- Annual bonus based on company performance
- Healthcare and wellbeing programs
- Pension plan membership
- Shares and savings programme
- Performance with Choice programme offering remote or hybrid working model