Regulatory Affairs Manager, Pharma Safety & Efficacy (US)

Boehringer Ingelheim Pharmaceuticals, Inc; Athens (OH); On-site; USD 140,000 - 180,000; Full time

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in the United States seeks a Manager, RA Pharma Safety & Efficacy to lead regulatory strategy for development projects. This role interfaces with internal teams and external stakeholders (FDA) to secure timely product approvals.

Responsibilities include coordinating safety/efficacy dossiers, FDA meetings, labeling input, and governance communications, while ensuring US regulatory compliance across projects.

Qualifications

• Advanced degree (DVM or PhD) with 2+ years in Regulatory Affairs.
• Masters in relevant science with 7+ years in Regulatory Affairs.
• Excellent command of English, written and spoken.
• Regulatory Affairs or equivalent pharma industry experience required.

Responsibilities

• Ensure safety and efficacy dossier components for US and other markets.
• Coordinate input for FDA interactions and product labeling.
• Lead regulatory advice for timelines, costs, and approvals.
• Represent BI at external meetings and trade associations.
• Support regulatory tooling updates and infrastructure projects.
• Collaborate across global teams and manage multiple projects.

Skills

Regulatory Affairs

Project management

Communication skills

Collaborative mindset

Intrapreneurial spirit

Education

DVM or PhD in relevant discipline

Masters in relevant discipline

Job description

Boehringer Ingelheim Pharmaceuticals, Inc. in the United States seeks a Manager, RA Pharma Safety & Efficacy to lead regulatory strategy for development projects. This role interfaces with internal teams and external stakeholders (FDA) to secure timely product approvals.

Responsibilities include coordinating safety/efficacy dossiers, FDA meetings, labeling input, and governance communications, while ensuring US regulatory compliance across projects.