The Regulatory Affairs Fellowship position will provide post-doctoral pharmacists the opportunity to obtain broad exposure to US Regulatory Affairs functions including promotional review, product labeling and product therapeutic area activities.
This position will require the Fellow to develop competencies necessary to contribute to regulatory strategy and provide input on cross-functional teams to ensure successful development, registration and commercialization of products. The Fellow will be based at Boehringer Ingelheim’s U.S. headquarters in Ridgefield, CT, working within various therapeutic areas (TAs). The Fellow will also gain an understanding of the broad range of opportunities available to a pharmacist in the pharmaceutical industry.
Duties & Responsibilities:
Participate in regulatory affairs sub-teams to assist the US Regional Regulatory Lead and Global Regulatory Lead in providing strategic input to cross-functional product teams to aid in the successful development, registration, and commercialization of products in all phases of development
Gain exposure to the strategy for interactions with health authorities, including preparation for FDA meetings and responses to information requests
Develop proficiency in the critical evaluation of evolving regulatory trends in order to assess impact on drug development activities and development strategies
Gain an understanding of the applicable FDA regulations and guidance related to the development of prescription drug labeling as well as advertising and promotional labeling materials
Coordinate submissions to FDA as appropriate including but not limited to investigational new drug applications, annual reports, general FDA correspondence and amendments
Participate in the regulatory review of promotional and non-promotional materials as part of a multidisciplinary team (e.g. Medical, Legal, Regulatory Review, etc.)
Support the development of product labeling via a cross-functional team
Lead and execute a longitudinal research project or major submission within Regulatory Affairs
In the second year, enhance leadership and management skills by precepting the first year Fellow
Gain an understanding of corporate structure, regulatory considerations and the drug development process
Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim.
Strong intrapersonal, active listening and problem-solving skills with an ability to work well in a team environment
Highly motivated and shows initiative in contributing to team deliverables
Receptive to receiving and quickly implementing constructive feedback
Ability to work independently within provided guidance from team leads
Adaptable and able to contribute to multiple Therapeutic Areas as needed
Excellent verbal and written communication skills
Proven experience working in a dynamic, high volume environment handling multiple tasks
Strong computer skills, including Outlook, Word, PowerPoint, and Excel
Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy Practice Experience [APPE] rotation is preferred but not required.
Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Additional Salary Information: The fellow will receive a competitive stipend and benefits package.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim is focused on science that leads to more health for our patients and their families. The discovery and development of innovative medicines is fundamental to our continued growth and success. Our blueprint for innovation is tailored to accelerate the delivery of breakthrough medicines to the patients we serve by integrating research, pre-clinical and early clinical development, translational medicine, and external partnering functions. This fusion of expertise combined with a dynamic research approach and an increased emphasis on external collaborations means we can effectively incubate the most creative ideas and be among the pioneers in emerging fields of medicine.