Regulatory Affairs Postdoc — CMC for US NDA Submissions

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

Benefits offered by this job

Competitive compensation

Global opportunities

Job summary

Boehringer Ingelheim offers a Clinical Development and Medical Affairs Fellow position at its U.S. headquarters in Ridgefield, CT.

This post-doctoral fellowship provides broad exposure to medical affairs, scientific communications, regulatory affairs, and translational medicine across multiple therapeutic areas. The fellowship includes rotations within or outside assigned areas, exposure to US FDA processes, and opportunities to contribute to regulatory submissions, labeling changes, and

Qualifications

• PharmD degree required or PhD in a related field.
• Ability to perform MEDLINE and EMBASE literature searches.
• Strong interpersonal, listening, and problem-solving skills.
• Excellent verbal and written communication abilities.

Responsibilities

• Develop regulatory expertise across therapeutic areas.
• Coordinate regulatory activities for FDA compliance in US.
• Author, review and update CMC documentation for US products.
• Serve as liaison with FDA and regulatory teams.

Skills

Communication skills

Team collaboration

Problem solving

Fast learner

Education

PharmD degree

PhD in related discipline

Tools

Outlook

Word

PowerPoint

Excel

Job description

Boehringer Ingelheim offers a Clinical Development and Medical Affairs Fellow position at its U.S. headquarters in Ridgefield, CT.

This post-doctoral fellowship provides broad exposure to medical affairs, scientific communications, regulatory affairs, and translational medicine across multiple therapeutic areas. The fellowship includes rotations within or outside assigned areas, exposure to US FDA processes, and opportunities to contribute to regulatory submissions, labeling changes, and