Regulatory Affairs

Boehringer Ingelheim is proud to offer a two-year fellowship within Regulatory Affairs. The Fellow will obtain in-depth and hands-on experience in regulatory strategy, with the opportunity to complete rotations to gain exposure to various Regulatory Affairs functions. Upon completion of the program, the Regulatory Affairs fellow will have gained the foundational knowledge and key competencies to begin a career in the dynamic field of Regulatory Affairs.

• 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).
• 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.

If interested in applying for this position, please apply here.