Post-Doctoral Fellow Regulatory Affairs - Chemistry, Manufacturing & Control

The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to, Medical Affairs and Scientific Communications, clinical operations, translational medicine, clinical pharmacology, and regulatory affairs. This position requires the Fellow to develop competencies necessary to contribute to their respective functional area within a pharmaceutical company. The Fellow will be based at Boehringer Ingelheim's U.S. headquarters in Ridgefield, CT, working on one or multiple therapeutic areas such as cardiology, diabetes, immunology, oncology, and respiratory. Through rotations within or outside the assigned area, the Fellow will gain an understanding of the broad range of opportunities available to a pharmacist in the industry. As an employee, you will contribute to the discovery, development, and delivery of products to patients and customers. Our global presence offers opportunities for international collaboration, visibility, and contribution to the company's success. We support our employees through fostering a healthy work environment, meaningful work, mobility, networking, and work-life balance. Our competitive benefits reflect our high regard for our employees. The Regulatory Affairs (RA) Fellowship within the Chemistry, Manufacturing and Controls (CMC) discipline is designed to provide pharmacists with a 2-year exposure to regulatory aspects of CMC during the lifecycle of BI assets. The Fellow will gain experience coordinating regulatory activities required of an NDA Holder for compliance with FDA requirements for U.S. products in BIPI's portfolio, including management of CMC and product labeling changes, and preparing/submitting supplemental applications and post-marketing reports. The Fellow will work on projects involving both US marketed products and early-phase US INDs. Under supervision, the Fellow will: Act as a liaison with the FDA. Research regulatory CMC standards and departmental policies. Provide strategic regulatory input for US marketed products. Author, review, and update CMC documentation for US registered products. Regulatory Expertise:

The Fellow will develop regulatory knowledge in therapeutic areas and dosage forms, interacting effectively within Regulatory Affairs and across CMC functions to advocate for regulatory goals. Manage CMC lifecycle changes, supporting local change review committees and assessing regulatory impacts. Review and approve regulatory documents for submissions, construct in eCTD format, and file supplemental NDAs. Manage NDA post-marketing reports, including annual reports and adverse experience reports. Liaise with the FDA and support FDA meetings. Act as US Agent for Type II DMFs and support product labeling review. Ensure compliance with CPD-3 database updates. Position Requirements: Doctor of Pharmacy degree from an ACPE-accredited school or a Ph.D. in a related discipline. Ability to perform literature searches (MEDLINE, EMBASE). Strong interpersonal, communication, and problem-solving skills. Motivated, proactive, and able to work independently and in teams. Adaptable to multiple therapeutic areas and fast-paced environments. Proficient in Outlook, Word, PowerPoint, and Excel. Desired experience includes prior pharmaceutical industry exposure, such as internships or rotations, though it is not mandatory.

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