Regulatory Affairs Fellow, CMC (Postdoc)

Boehringer Ingelheim GmbH; Ridgefield (CT); On-site; USD 95,000 - 130,000; Full time

Job summary

Boehringer Ingelheim is seeking a Postdoctoral Fellow in Regulatory Affairs (CMC) based at our Ridgefield, CT headquarters. The 2-year fellowship provides exposure to US regulatory processes, NDA lifecycle management, and interactions with FDA, across multiple therapeutic areas.

The role emphasizes CMC documentation, labeling changes, and strategic regulatory input for US products. The Fellow will gain hands-on experience coordinating regulatory activities, coordinating with RA and

Qualifications

• Doctor of Pharmacy degree required; ACPE-accredited.
• Excellent verbal and written communication skills.
• Ability to perform literature searches (MEDLINE/EMBASE).
• Strong initiative, adaptability, and teamwork in a dynamic environment.
• Experience working in a high-volume pharmaceutical setting is a plus.

Responsibilities

• Act as a company liaison with the FDA.
• Research regulatory CMC standards and policies.
• Provide regulatory input for US marketed products.
• Author, review, and update CMC documentation for US products.
• Manage NDA-related submissions and post-marketing reports.
• Coordinate with cross-functional teams on regulatory activities.

Skills

Regulatory affairs basics

Communication skills

Teamwork and problem solving

Microsoft Office proficiency

Education

Doctor of Pharmacy degree

Ph.D. in related discipline

Tools

Microsoft Office

Job description

Boehringer Ingelheim is seeking a Postdoctoral Fellow in Regulatory Affairs (CMC) based at our Ridgefield, CT headquarters. The 2-year fellowship provides exposure to US regulatory processes, NDA lifecycle management, and interactions with FDA, across multiple therapeutic areas.

The role emphasizes CMC documentation, labeling changes, and strategic regulatory input for US products. The Fellow will gain hands-on experience coordinating regulatory activities, coordinating with RA and