Regulatory Affairs Manager - Pharma Safety & Efficacy

Boehringer Ingelheim GmbH; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Boehringer Ingelheim is seeking a Manager, RA Pharma Safety & Efficacy to lead US regulatory strategy for development projects. You will coordinate FDA meetings, ensure US requirements are met, and link regulatory affairs to internal and external stakeholders.

The role emphasizes collaboration in a global organization, building robust regulatory plans, and driving timely product approvals across markets.

Qualifications

• Advanced degree with regulatory experience in pharma or veterinary products.
• Proven experience in regulatory strategy, FDA interactions, and dossier preparation.

Responsibilities

• Lead safety and efficacy regulatory activities for US projects.
• Coordinate information for FDA meetings and submissions.
• Provide regulatory strategy and governance to cross-functional teams.

Skills

Regulatory affairs

Pharma industry

English proficiency

Global collaboration

Education

Advanced degree (DVM or PhD)

Masters in science (7+ years)

Job description

Boehringer Ingelheim is seeking a Manager, RA Pharma Safety & Efficacy to lead US regulatory strategy for development projects. You will coordinate FDA meetings, ensure US requirements are met, and link regulatory affairs to internal and external stakeholders.

The role emphasizes collaboration in a global organization, building robust regulatory plans, and driving timely product approvals across markets.