Post-Doctoral Regulatory Affairs Fellow - Policy and Intelligence

The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that offers broad exposure to BI US Medical functions, including Medical Affairs, Scientific Communications, clinical operations, translational medicine, clinical pharmacology, and regulatory affairs. The Fellow will develop competencies to contribute within their respective functional area in a pharmaceutical company. Based at Boehringer Ingelheim's U.S. headquarters in Ridgefield, CT, the Fellow will work across multiple therapeutic areas such as cardiology, diabetes, immunology, oncology, and respiratory. Through rotations within or outside their assigned area, the Fellow will gain insight into various opportunities available to pharmacists in the industry. As a Boehringer Ingelheim employee, you will contribute to the discovery, development, and delivery of products to patients and customers, with opportunities for international collaboration, visibility, and professional growth. We support our employees through a healthy work environment, meaningful work, mobility, networking, and work-life balance, complemented by competitive compensation and benefits. The Regulatory Policy and Intelligence Fellowship aims to provide pharmacists with exposure to regulatory intelligence and policy activities within the pharmaceutical industry. The position includes rotations in and beyond Regulatory Affairs. The Fellow will work on projects involving US marketed and investigational products, developing skills such as: Regulatory intelligence gathering from health authorities, professional groups, and internal sources. Communication of regulatory intelligence within the organization. Analysis and guidance on US regulatory strategies to expedite product development and approval. Research on regulatory policies and departmental procedures. Process improvement in regulatory intelligence and collaboration. Development of expertise in regulatory intelligence and policy projects. Collaboration with Government Affairs for knowledge sharing. Regulatory Expertise: The Fellow will acquire foundational knowledge of regulatory policies across BI assets and products, interacting effectively within Regulatory Affairs and cross-functionally as a US regulatory advocate under supervision. Responsibilities include: Reviewing US regulations and guidelines, monitoring regulatory trends impacting drug and device development. Requesting and evaluating global regulatory information. Developing reports to support compliance and strategy. Supporting compliance initiatives. Refining FDA guidance and preparing comments for health authorities. Evaluating new regulatory intelligence sources. Leading regulatory intelligence on cross-functional teams. Providing updates on global regulatory policy issues. Participating in product team meetings for regulatory context. Advising on regulatory strategies for drug development and marketed products. Creating training materials on regulatory requirements. Analyzing the impact of emerging policies. Coordinating feedback on laws and regulations with trade organizations. Collaborating with Government Affairs on legislative proposals. Automating regulatory information processes. Position Requirements: Doctor of Pharmacy degree from an ACPE-accredited institution earned prior to start date. Proficiency in MEDLINE and EMBASE literature searches. Strong interpersonal, listening, and problem-solving skills; team-oriented. Motivated, proactive, receptive to feedback, and able to work independently. Adaptable to multiple therapeutic areas. Excellent communication skills. Experience in high-volume, multitask environments. Computer proficiency in Outlook, Word, PowerPoint, Excel. Understanding of corporate structure, regulatory considerations, and drug development in pharmacy. Preferred Qualifications: Prior pharmaceutical industry experience, such as internships or APPE rotations, is preferred but not required.

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