Regulatory Affairs Jobs at Boehringer Ingelheim Germany
This senior leadership role represents one of the most impactful Regulatory Affairs Jobs available today for professionals seeking to influence global healthcare outcomes. Offered by Boehringer Ingelheim, this Global Regulatory Strategy Lead position in Germany provides a unique job opportunity for life science graduates and experienced professionals alike to shape regulatory pathways for transformative therapies across cardiovascular, renal, and metabolic diseases.
About Boehringer Ingelheim
Boehringer Ingelheim is a global biopharmaceutical company active in human and animal health. Founded in 1885 and independently owned, the company takes a long-term, sustainable approach to innovation and R&D. With approximately 54,500 employees across 130+ markets, Boehringer Ingelheim focuses on improving and extending lives in areas of high unmet medical need.
Job Details:
- Job Title: Global Regulatory Strategy Lead
- Job ID: 25587
- Job Function: Medicine
- Career Level: Leadership
- Organization: BI International GmbH
- Working Time: Full-Time
- Job Flexibility: Hybrid
- Primary Locations: Biberach, Germany; Ingelheim, Germany
The Regulatory Affairs Job Position
Boehringer Ingelheim is seeking a Global Regulatory Strategy Lead (GRSL) to join our highly collaborative and innovative Global Regulatory Affairs (GRA) team. In this pivotal leadership role, you will partner with cross-functional colleagues to help bring transformative therapies to patients within the Cardiovascular, Renal, and Metabolism (CRM) therapeutic area.
As a GRSL (also known as a Global Regulatory Lead in other organizations), you will lead the development and execution of global regulatory strategies across a diverse portfolio, spanning early- to late-stage assets, multiple modalities, and advanced technologies.
You will help shape treatments for conditions including:
- Heart Failure
- Myocardial Infarction
- Chronic Kidney Disease
- Obesity
- NASH / MASH / Liver Cirrhosis
Key Activities & Responsibilities
- Serve as the primary regulatory interface and strategic partner for cross-functional project teams
- Lead the Regulatory Excellence Team (RET) with full accountability for global regulatory strategy development and execution
- Oversee all global regulatory activities, including authorship of the Global Regulatory Strategy document
- Contribute to core deliverables such as the Target Product Profile (TPP) and target label
- Drive regulatory interactions with health authorities in key strategic markets, in collaboration with regional and local GRA teams
- Review and provide strategic input on:
- Clinical trial protocols and study reports
- INDs / CTAs
- Pediatric development plans
- Core dossier components
- Ensure compliance with global regulatory standards, SOPs, and best practices
- Stay current on scientific, regulatory, and commercial developments in the CRM therapeutic area
- Integrate insights from pharmacovigilance, market access, and medical affairs
Requirements for Regulatory Affairs Job
- Advanced degree in Life Sciences (Master’s or Doctorate)
- Additional certifications (e.g., Specialized Pharmacist, Master’s in Drug Regulatory Affairs) are a strong asset
- Extensive experience in pharmaceutical or biotechnology R&D
- Deep expertise in Global Regulatory Affairs
- Therapeutic area experience in Cardiovascular, Renal, and/or Metabolism (CRM) strongly preferred
- Proven success in global regulatory strategy development and execution, including:
- (s)BLA / (s)NDA / MAA submissions
- INDs / CTAs
- Health Authority briefing documents
- Direct negotiations with agencies such as FDA and EMA
- Strong knowledge of global regulatory guidelines and internal SOPs
- Ability to analyze complex scientific and regulatory frameworks under pressure
- Excellent leadership, interpersonal, and stakeholder-influencing skills
- High business acumen with strong written and verbal communication
- Confident decision-making, negotiation, and problem-solving abilities in a global matrix environment
Recruitment Process
- Online application – Posting expected to remain open until February 28, 2026
- Virtual interviews – Beginning early March
- On-site interviews – Beginning / mid-April
Why Join Boehringer Ingelheim?
- Work on a rich, high-impact pipeline with strong scientific and strategic relevance
- Collaborate with deeply experienced, science-driven colleagues
- Contribute across the full product lifecycle—from development and registration to lifecycle management
- Make a meaningful global impact in a fast-paced, forward-thinking environment
