5 months ago
A small clinical-stage pharmaceutical client of ours has a new opening for an SVP of Regulatory Affairs located in New Jersey. They are a leader in the field of oncology therapeutics and their objective is to improve the quality of life for patients facing rare cancers.
The role would be in charge of regulatory strategy and submissions for approval to the respective authorities. This person will also directly report into the CEO.
- Provide regulatory strategy for Regulatory Affairs and CMC
- Engage with all FDA, EMA and Health Canada interactions including any other regulatory authorities
- Lead label negotiations
- Recognize opportunities to build scientific credibility, trust, and partnership with stakeholders within the Health Authority to lead to engagement with the FDA and accelerated development
- Lead NDA clinical strategy
- Draft and be responsible for all key regulatory documents such as IMPD, IND, IB, etc.
- Support health authority with PAI, GMP, etc supplier inspections
- Attend relevant FDA/EMA public meetings that are relevant such as input on guidance, advisory committee, and patient engagement
- Ensure operations are timely and compliant for all require reporting responsibilities, regulatory updates, and submissions
- Masters/ PhD in a Life Sciences discipline is preferred
- 15-20 years of experience in the biopharma industry
- 10+ years of experience within CMC regulatory affairs
- Previous experience filing NDAs to completion
- Previous experience leading Phase III clinical trial submissions
- Experience with creating and managing IMPDs, INDs, NDAs
- Proven track record of working with the EMA/FDA in an effective manner acting as a respected spokesperson
- Experience leading and growing a successful team
This role is actively interviewing candidates, please send your CV to Marissa, at email@example.com for consideration.