Regulatory Affairs Manager — Pharma Safety & Efficacy

Boehringer Ingelheim GmbH; Athens (GA); On-site; USD 120,000 - 190,000; Full time

Job summary

Boehringer Ingelheim is seeking a Manager, RA Pharma Safety & Efficacy in the US to lead regulatory strategies for development projects and ensure timely approvals. You will interface with FDA and coordinate with project teams to align safety and efficacy dossiers with regulatory expectations.

The role requires strong English communication, collaboration across global teams, and the ability to manage multiple projects in a fast-paced environment.

Qualifications

• Advanced degree (DVM or PhD) with 2+ years regulatory experience.
• Alternatively, Master’s in a relevant field with 7+ years regulatory experience.
• Excellent command of English, written and spoken.
• Regulatory affairs experience in pharma industry is required.
• Ability to collaborate globally and manage multiple projects.

Responsibilities

• Represent US RA Safety & Efficacy in global development projects.
• Provide regulatory strategy to ensure timelines for product approval.
• Lead FDA meetings and submissions for assigned projects.
• Coordinate regulatory input with internal and external stakeholders.
• Contribute to governance reviews, project teams, and communications.

Skills

Regulatory affairs

English language

Multitasking

Education

DVM

PhD

Master's degree

Job description

Boehringer Ingelheim is seeking a Manager, RA Pharma Safety & Efficacy in the US to lead regulatory strategies for development projects and ensure timely approvals. You will interface with FDA and coordinate with project teams to align safety and efficacy dossiers with regulatory expectations.

The role requires strong English communication, collaboration across global teams, and the ability to manage multiple projects in a fast-paced environment.