Global Regulatory Strategy Lead

Overview

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. You will lead the development and execution of global regulatory strategies across a diverse and dynamic portfolio, including early- to late-stage assets, spanning multiple modalities and technologies. You’ll help shape treatments for conditions such as Heart failure, Myocardial infarction, Chronic kidney disease, Obesity, NASH/MASH/liver cirrhosis.

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

Contact and Recruitment

Ready to contact us? If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) or via mail:

Recruitment process

1. Online application - The job posting is presumably online until February 28th, 2026
2. Virtual meeting starting from beginning of March
3. On-site interviews beginning/mid of April

Company and Why Boehringer Ingelheim

Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations. Visit the Boehringer Ingelheim website: