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Global Regulatory Strategy Lead

The Position

Join our highly collaborative and innovative Global Regulatory Affairs (GRA) team at Boehringer Ingelheim as a Global Regulatory Strategy Lead (GRSL). In this pivotal role, you will partner with cross-functional colleagues to help bring transformative therapies to patients in the Cardiovascular, Renal, and Metabolism (CRM) therapeutic area.
As a GRSL (also known as Global Regulatory Lead (GRL) in other organisations), you will lead the development and execution of global regulatory strategies across a diverse and dynamic portfolio. This includes early- to late-stage assets, spanning multiple modalities and technologies. You’ll play a key role in shaping the future of treatments for conditions such as Heart failure, Myocardial infarction, Chronic kidney disease, Obesity, NASH/MASH/liver cirrhosis.
Why Join Us?

  • Work on a rich and varied pipeline with high scientific and strategic impact.
  • Collaborate with deeply experienced, science-driven colleagues across the organization.
  • Contribute to the full product lifecycle—from development and registration to lifecycle management and maintenance.

If you're passionate about regulatory science and ready to make a global impact in a fast-paced, forward-thinking environment—we want to hear from you!

This position can be filled in different countries.​
If you want to apply for the position in the USA, please use this link: coming soon

Activities & responsibilities

  • Serve as the primary regulatory interface and strategic partner for cross-functional project teams and related sub-teams.
  • Lead the Regulatory Excellence Team (RET) and take full accountability for the development and execution of innovative, science-driven global regulatory strategies for assigned projects.
  • Oversee all global regulatory activities, including the authorship of the Global Regulatory Strategy document and contributions to key project deliverables such as the Target Product Profile (TPP) and target label.
  • Drive regulatory interactions with health authorities in key strategic markets, in close collaboration with regional and local GRA colleagues.
  • Review and provide strategic input on critical regulatory documents, including clinical trial protocols, study reports, CTAs/INDs, pediatric development plans, and core dossier components.
  • Ensure compliance with global regulatory standards and contribute to the development and implementation of departmental policies and best practices.
  • Stay current with the latest scientific, regulatory, and commercial developments in the Cardiovascular, Renal, and Metabolism (CRM) therapeutic area, including insights from pharmacovigilance, market access, and medical affairs.

Requirements

  • Advanced degree in pharmacy or life sciences (e.g., Master’s or Doctorate). Additional certifications such as Specialized Pharmacist or a Master’s in Drug Regulatory Affairs are considered a strong asset.
  • Long term experience in pharmaceutical or biotechnology R&D, with a deep understanding of Global Regulatory Affairs.
  • Therapeutic area expertise in Cardiovascular, Renal and/or Metabolism (CRM) is highly preferred.
  • Proven track record in developing and executing global regulatory strategies, including successful preparation and submission of (s)BLA / (s)NDA / MAA, INDs / CTAs, Health Authority briefing documents, as well as direct negotiation experience with major regulatory agencies (e.g., FDA, EMA)
  • Strong knowledge of global regulatory guidelines and internal SOPs/working instructions.
  • Demonstrated ability to analyze complex scientific data and regulatory frameworks, with a calm and focused approach under pressure.
  • Excellent interpersonal and leadership skills, with the ability to build strong cross-functional relationships and influence internal and external stakeholders.
  • High level of business acumen, strategic thinking, and persuasive communication—both written and verbal.
  • Strong decision-making, negotiation, and problem-solving capabilities in a global, matrixed environment.

Ready to contact us?  

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com 

Recruitment process: 
Step 1: Online application - The job posting is presumably online until November 24th, 2025 
Step 2: Virtual meeting starting from mid November
Step 3: On-site interviews end of November - beginning of December 

 

Apply now »