17 days ago
Our client is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies is now recognized as one of the world’s leading Immuno-Oncology based providers is currently hiring for a Regulatory Affairs professional to join the team. The Regulatory Affairs (CMC), Senior Manager will be responsible for providing operational and life cycle management in support of marketed and early stage products.
Main responsibilities include:
- Supporting all aspects of regulatory CMC submissions with regard to commercial and developmental programs.
- You will be the Regulatory CMC lead on program teams by applying specialist knowledge of regulations to interpret technical regulatory guidelines, that will ultimately mean that all regulatory submissions are in compliance with applicable regulations
- Strategize on deliverables to ensure M3 content meets regulatory requirements and projected business timelines
- Align CMC regulatory strategy to overall regulatory business strategy and to be responsible for assessment of all CMC related changes, when needed
- You will participate as part of a project team and be required to lead a technical task force in meetings around RA/CMC related activities.
- Bachelor’s degree and 7+ years of relevant US regulatory (FDA) / drug development experience required.
- An advanced degree (MS/PhD) would be preferred (but not required)
- Experience working at a large Biotechnology company is preferred
If this opportunity interests you, please get in touch today so that we can provide a full job description and explore in more detail!