Postdoctoral Regulatory Affairs Fellow - Product Strategy

Boehringer Ingelheim is seeking a Postdoctoral Regulatory Affairs Fellow to gain broad exposure to Regulatory Affairs strategy through rotations and projects involving marketed and investigational products. The Fellow will support US regulatory strategy, FDA interactions and submissions, regulatory intelligence, and cross-functional drug development activities under supervision.

What you'll do:

• The Fellow will develop basic regulatory strategy 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
• As a regulatory professional with basic knowledge in one or more therapeutic areas, interact effectively at all levels of the organization (local and global), within Regulatory Affairs and across functions, as a US regulatory advocate to achieve common goals for assigned projects
• Effectively contribute US operational and strategic perspectives to RA subteam to ensure GRL 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
• In collaboration with the GRL and RA sub-team, provide leadership in the development and implementation of US regulatory strategy within a global development context
• Assess US strategic options and provide US regulatory advice to support assigned global development projects and Product Maintenance Optimization strategies, seeking US project team/management alignment as appropriate
• Assess opportunities for expedited US regulatory pathways. Define US strategic considerations in the generation of a Global Regulatory Strategy Document
• In cooperation with US/Global Labeling, provide project-related US regulatory input into content of the draft CCDS
• Provide US guidance to global team on FDA submissions, meetings, and pediatric development requirements including preparation of documentation, as appropriate
• Act as a company liaison with the US Food and Drug Administration
• Provide analysis, advice and guidance on US regulatory strategies

What they're looking for:

• Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim OR Ph.D. degree in related discipline
• Ability to perform MEDLINE and EMBASE literature searches
• 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
• Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with an ability to quickly adapt to a changing Corporate environment that will allow the incumbent to be productive in rotational experiences
• Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy Practice Experience [APPE] rotation is preferred but not required.)

Benefits:

• The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.
• Hybrid work arrangement.
• The position offers the opportunity to complete rotations in areas within and beyond Regulatory Affairs.
• Opportunity to collaborate internationally, with visibility and opportunity to directly contribute to the company's success.