RA Manager, Veterinary Safety & Efficacy

Boehringer Ingelheim; Athens (GA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Boehringer Ingelheim Animal Health USA seeks an experienced Manager, RA Pharma Safety & Efficacy to lead regulatory strategy for development projects in the US. You will handle FDA meetings, submissions, and ensure alignment of regulatory activities with internal stakeholders across global development projects.

The role requires strong English communication, a background in Regulatory Affairs within the pharma industry, and the ability to manage multiple projects in a fast-paced environment.

Qualifications

• Advanced degree (DVM or PhD) with minimum 2 years related experience in Regulatory Affairs or related pharmaceutical industry experience.
• Alternatively, Master’s in a relevant science with at least 7 years in Regulatory Affairs.
• Excellent command of English in speaking and writing.
• Regulatory Affairs/pharma industry experience required.

Responsibilities

• Lead safety and efficacy dossier work for veterinary products in US and other markets when applicable.
• Coordinate input for FOI summaries and product labeling for assigned projects.
• Work in cross-functional project teams to drive Target Product Profile objectives.
• Provide regulatory advice on pathways to approvals including timelines, costs, and market viability.
• Represent BI at external functions and trade associations to support BI interests.
• Contribute to regulatory due diligence and evaluation of dossiers for compliance.

Skills

Regulatory Affairs

English proficiency

Project coordination

Stakeholder communication

Education

Doctor of Veterinary Medicine

PhD in relevant discipline

Master's in relevant science

Job description

Boehringer Ingelheim Animal Health USA seeks an experienced Manager, RA Pharma Safety & Efficacy to lead regulatory strategy for development projects in the US. You will handle FDA meetings, submissions, and ensure alignment of regulatory activities with internal stakeholders across global development projects.

The role requires strong English communication, a background in Regulatory Affairs within the pharma industry, and the ability to manage multiple projects in a fast-paced environment.