Senior Manager Regulatory CMC
Do you want to shape regulatory strategy for cutting-edge advanced therapies?
Are you ready to lead complex CMC regulatory activities across clinical and commercial programmes?
Do you enjoy working at the forefront of innovation in gene therapy development?
Fraser Dove International is partnering exclusively with a pioneering biotechnology organisation. Operating in Italy, they are committed to advancing innovative therapies to address unmet medical needs.
Our client is seeking a strategic leader to drive CMC regulatory activities and guide product development across the lifecycle.
Discover more about our Senior CMC Regulatory Affairs Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
Your objectives:
As the Senior CMC Regulatory Affairs Manager, you will be measured against the following objectives:
- Develop and execute robust CMC regulatory strategies that support clinical development and commercial readiness
- Ensure timely, high-quality regulatory submissions and approvals across global markets
- Strengthen cross-functional collaboration and regulatory compliance to support innovation and product lifecycle management
What you will do:
As the Senior CMC Regulatory Affairs Manager, your duties and responsibilities will include:
- Lead CMC regulatory strategy for clinical and commercial stage products, including preparation of dossier sections and risk assessments
- Collaborate with regulatory authorities such as the European Medicines Agency (EMA) and Food and Drug Administration (FDA) to define development pathways
- Manage regulatory submissions including Investigational New Drug (IND), Biologics License Application (BLA), Marketing Authorisation Application (MAA), and variations
- Support inspections and regulatory interactions, ensuring compliance of CMC documentation
- Oversee supplier and Contract Development and Manufacturing Organisation (CDMO) regulatory activities and ensure compliance with Good Manufacturing Practice (GMP)
- Contribute to innovation in development platforms, particularly in gene therapy and advanced therapies
- Monitor regulatory changes and assess impact on development and submission strategies
What you will bring:
These are the skills and experience you will need to succeed as the Senior CMC Regulatory Affairs Manager:
- 8 to 10 years of experience in CMC regulatory affairs within the biopharmaceutical industry
- Proven experience delivering regulatory strategies and submissions across clinical and commercial stages
- Experience engaging with regulatory authorities such as EMA and FDA
- Strong leadership and stakeholder management capabilities
- Deep understanding of GMP, quality systems, and regulatory compliance
- Bachelor of Science (BSc) in a relevant scientific discipline
- Doctor of Philosophy (PhD) or equivalent postgraduate qualification is desirable
Got what it takes?
To apply for the Senior CMC Regulatory Affairs Manager, click the ‘Apply’ button below or contact the Executive Search Consultant – Thomas Castling – on +44 (0)203 355 7050.
Please Note:
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related.