Telecommute Medical Regulatory Affairs Senior Director or Vice President

Job Summary

A staffing agency has a current position open for a Telecommute Medical Regulatory Affairs Senior Director or Vice President.

Must be able to:

• Advise on all regulatory activities
• Assist with developing day-to-day and long range global regulatory plans
• Guide submissions to the regulatory authorities

Qualifications Include:

• An advanced degree in the sciences (e.g. MD, PhD, PharmD)
• A successful track record interacting with the FDA and other regulatory governing bodies
• 7 to 10 years experience, including in-house at a biotech or pharmaceutical company
• Proficiency in executing submissions of the following: IND, NDA, MAA, CTA
• Demonstrated leadership and team building experience skills