Boehringer Ingelheim GmbH
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!
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
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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!
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
#J-18808-Ljbffr