Senior Manager/Associate Director Regulatory Affairs
We are looking for a Senior Manager or Associate Director of Regulatory Affairs to join a growing, global pharmaceutical company in New Jersey. You will take the lead on preparing IND’s, developing regulatory strategies, and also planning for health authority meetings. This company has a relaxed, yet professional office environment with low employee turnover. This is an exciting time to join as they recently acquired another company and also received Breakthrough Therapy Designation from the FDA for one of their orphan disease programs. This position offers ample opportunity for visibility and growth as you take the next step in your career.
Responsibilities:
- Ensure regulatory strategies are developed and implemented; ensuring worldwide regulatory compliance
- Liaise with interfaces, participate in cross-functional teams, coordinate the label management team
- Prepare submission and response packages for all procedure types including Health authority interactions
- Manage CMC-related change control process to ensure adequate assessments
- Highlight opportunities and risks and propose measures for mitigation
- Provide broad procedural support to ensure the delivery of product team and business objectives
Knowledge and Skills:
- Minimum BS required; MS or PhD is a plus
- A minimum of 5 years of Pharmaceutical industry experience with a minimum of 2-3 years spent in Regulatory Affairs
- Must have experience related to preparation of an IND in support of agency filing
- Must have experience with early stage regulatory development
- Must be able to readily interact with internal teams to assess the best path forward
- Must be able to compile documentation in support of an agency meeting
- Have understanding of the complexity of various regulatory developments