The Regulatory Affairs Fellowship is designed to provide pharmacists with exposure to all areas within Regulatory Affairs including the Product Therapeutic Areas, Chemistry Manufacture and Controls (CMC), Promotional Review and Labeling. The position will also offer the opportunity to complete several months of rotations in areas beyond Regulatory Affairs.
The Fellow, under supervision, will be exposed to projects involving both US marketed products and investigational projects. Under supervision, the Fellow will:
Act as a company liaison with the US Food and Drug Administration.
Provide analysis, advice and guidance on US regulatory strategies.
Research information on regulatory standards and departmental policies.
Provide advice as it pertains to labeling and promotional review and CMC issues
Develop expertise on projects in the assigned therapeutic area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance, market access and commercial perspective.
The Fellow will develop basic regulatory expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory advocate to achieve common goals for assigned projects, with supervision.
RA Subteams and Intra-RA Project Responsibilities:
Effectively contribute US operational and strategic perspectives to RA subteam to ensure TMRA and the subteam accurately consider US regulatory requirements and challenges in the global context.
Present or support review of US-specific regulatory topics to Regulatory Expert Group (REG), as appropriate.
Ensure US RA contributions to all local and global project related documentation such as management summaries, TALC / HPSC / DC pre-reads, are clear, complete and accurate, taking on leadership of the information as appropriate.
Project Team Support:
In collaboration with Regulatory colleagues, the Fellow will provide information regarding the development and implementation of US regulatory strategy within assigned project/area.
Assess US strategic options and provide US regulatory advice to support assigned projects and Product Maintenance Optimization strategies, seeking US project team/management alignment as appropriate.
Provide US regulatory input on development of the package insert, promotional review materials or CMC activities as appropriate.
Provide input on initial proposed draft labeling for submission to FDA ensuring appropriate supportive information is provided.
Provide input on promotional review materials consistent with FDA guidelines and requirements.
Health Authority Interactions/Submissions:
Assist with FDA interactions on assigned projects/products, including formal meetings, FDA review of registration packages, and labeling negotiations.
Contribute to development of US regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RA Subteam.
Provide regulatory input in preparing responses to FDA requests.
Attend FDA meetings for assigned projects.
Contribute to formal submissions and informal communications to FDA for assigned projects/products.
Other Regulatory Contributions:
Provide US strategic regulatory guidance and input to key internal development, registration and commercialization documents for assigned projects (e.g. development plans, protocols, clinical trial reports, pediatric development plans, core dossier elements, integrated brand plans, market access documents), with particular emphasis on the US contribution within the strategic country prioritizations (i.e., “hyperfocus”).
Provide US regulatory leadership in the preparation, content, and distribution in the US of critical safety or quality communications (including DHCP letters)for assigned projects/products, with guidance from management, TM RA, US Legal, and GPV, as appropriate.
As defined by respective BI processes, review and release, via cross-functional Medical-Legal-Regulatory team, US core messages, as appropriate (e.g., press release, stand-by statements).
The Fellow will, under the supervision of a Global Regulatory Lead, participate in global cross-functional meetings to understand the basics of global regulatory strategy and process.
Proactively review and evaluate relevant US regulations and guidelines, as well as evolving regulatory trends and developments for their impact on drug development activities and on existing development strategies.
Share new/novel "on the job" US regulatory intelligence/experience with peers, as appropriate.
Basic knowledge of pharmacy gained through Doctor of Pharmacy program
Fellow should have basic understanding of:
Food, Drug and Cosmetic Act.
21 CFR regulations relevant to drug/biologic development and registration.
Other relevant US laws, regulations and guidance documents.
Medical, pharmaceutical and scientific knowledge and understanding in the assigned therapeutic area.
Minimum qualifications, education, experience:
Doctor of Pharmacy degree
Critical thinker with ability to self-direct workload, including reprioritizing and delivery under tight timelines.
Ability to analyze and interpret scientific data and regulatory guidelines
Strong interpersonal skills, agility and willingness to adapt to a changing environment
Problem solving skills
Excellent oral and written communications skills with the ability to provide key messages in a concise manner.
Excellent meeting preparation and presentation skills.
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
About Boehringer Ingelheim
The post-doctoral fellowship program is based at Boehringer Ingelheim’s U.S. Headquarters in Ridgefield, CT. It serves to prepare pharmacy graduates for careers within the pharmaceutical industry.
BI has had a one-year Medical Information Fellowship program for over ten years, and is now offering 2-year programs in:
Medical Affairs & Scientific Communications
Translational Medicine & Clinical Pharmacology
Selected Fellows have the opportunity to collaborate autonomously across teams and departments while building confidence and skills.
If you are looking for a program that will give you first-hand experience across various roles in the pharmaceutical industry, help build a professional network, and position yourself for a career in the pharmaceutical industry then this is the program for you.