Description
I am representing a rapidly growing pharmaceutical organization in the Midwest who is actively looking for a VP/Director level candidate with experience directing, managing and coordinating Regulatory Affairs activities for the Pharmaceutical division. The position will require constant communication with Chief Medical Officer, Head of Research, and President to establish regulatory strategy and executable plan to US/International team sites. Candidate will direct regulatory activities associated with pre-clinical, clinical and CMC activities. This individual will be responsible for on boarding and managing all regulatory personnel, interfacing with outside consultants, and maintaining the budget for the division. This position requires a strong history interaction with FDA and other regulatory agency staff to answer questions, plan meetings, obtain information, and facilitate all regulatory interactions.Required skills include:
- Minimum of 10 years in regulatory affairs management positions within the pharmaceutical or biotechnology industry, with demonstrable accomplishments in regulatory affairs.
-Professional speaking and writing
-Experience overseeing preclinical development through post market evaluation
-Strong submission author/review history
-Proven leadership history and ability to work cross functionally
-Biological/Oncology drug experience preferred
-Bachelors Degree in scientific field, PHD preferred.