Job Summary
A staffing solutions company has a current position open for a Remote Regulatory Affairs Senior Director Vice President.
Candidates will be responsible for the following:
- Provide strategic regulatory expertise and guidance to the Regulatory Affairs team
- Perform oversight and implementation of all regulatory activities
- Develop global regulatory plans and strategies that support products
Applicants must meet the following qualifications:
- An advanced degree in the sciences (e.g. MD, PhD, PharmD)
- 7 to 10 years of professional experience, including in-house at a biotech or pharmaceutical company
- A successful track record interacting with the FDA and other regulatory governing bodies
- Proficiency in executing submissions of the following: IND, NDA, MAA, CTA.
