My client, with whom I have placed multiple professionals already in 2017, is a rapidly expanding clinical stage pharma located in a desirable suburban area adjacent to the well-known Research Triangle Park area of North Carolina with a healthy portfolio of drug products in their development pipeline (some in Phase III).
Reporting into a VP of Regulatory Affairs, the Senior Director, Regulatory Affairs, will be a hands-on and strategic leader who enjoys a fast-paced, dynamic work environment.
The Senior Director, Regulatory Affairs will be responsible for providing regulatory leadership in support of the development and regulatory approval for new drug products (NDAs, etc.).
He/she will provide leadership and develop strategies to ensure effective achievement of business objectives. The individual will also maintain awareness of current regulatory environment and assess and communicate impact of changes on business and product development programs.
Provide regulatory leadership in support of the development and regulatory approval of drug products within multiple therapeutics areas.
Ensure the efficient, timely and compliant execution of regulatory strategies.
Provide regulatory leadership during Regulatory Agency meetings.
Provide review and comments on regulatory documents.
Offer expert opinion, advice and strategic direction.
Provide regulatory due diligence assessments of new business opportunities as required.
Scientific degree (BS minimum requirement). Advanced degree (MS, Ph.D., PharmD, preferred)
A minimum of 10 years of regulatory affairsexperience in the pharmaceutical industry with a minimum of 3 years in a senior leadership role (Director level or above currently)
Extensive experience in regulatory with FDA (IND, NDA, BLAs, etc.).
Previously extensive interaction experience with the FDA – previous NDA approval record a plus.
Excellent verbal and written skills
Ability to think creatively and develop creative solutions
Strong personal and interpersonal skills
RAC certification strongly preferred, but not required