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(Senior) CMC RA Manager

The Position

Are you ready to take on a pivotal role with worldwide responsibility for CMC-regulatory aspects for biologicals across Development Projects, approved products and high-impact general strategic initiatives? Within our Group Global CMC Regulatory Affairs team, we are looking for an expert to lead initiatives that demand extraordinary regulatory expertise and strategic vision.

In this role, you will support complex, non-standard projects involving biologicals, multiple indications and formulations, also in collaboration with licensing partners. As a trusted expert, you will monitor developments in strategically important areas, assess their impact on Boehringer Ingelheim, and provide critical insights to colleagues in Regulatory Affairs and other key functions.

This is your opportunity to shape the future of regulatory excellence at Boehringer Ingelheim while driving innovation and ensuring compliance in a dynamic, global environment. Are you ready to make a difference?

Take the next step in your career and help us shape the future of data governance!

This position can be filled in different countries. 
This position can be filled in Ingelheim or Biberach, Germany.

Tasks & responsibilities

  • In this position, you will manage CMC regulatory activities for biologicals in development and for approved biologicals.
  • You will represent the department in global project and product teams and provide CMC regulatory advice regarding global regulatory requirements, CMC submission strategies, and opportunities for seeking scientific advice from health authorities.
  • Planning, defining, reviewing, and compiling global Module 3 documentation for Clinical Trial Applications, Marketing Authorization Applications, and post‑approval activities—including post‑approval changes and renewals—will form an essential part of the role.
  • Moreover, guiding project teams in preparing high‑quality global registration documents and responses to health authority requests will ensure that timelines are met.
  • You will review CMC documentation for in-licensing products.
  • You will drive acceleration and innovative regulatory strategies, also with the use of AI tools.
  • Acting as the representative for Global CMC Regulatory Affairs, you will contribute to interdisciplinary strategic projects internally and represent Boehringer Ingelheim in industry organizations externally.
  • Additionally, staying up‑to‑date on the global CMC regulatory environment—including ICH, FDA, EMA, PMDA, CDE, and Emerging Markets—will be fundamental.
  • Coaching less experienced colleagues and deputizing for the team lead, when needed, will round off your responsibilities.

Requirements

  • Master's degree in Biotechnology, Biochemistry, Pharmacy, Chemistry, or Biology
  • Experience in CMC development and/ or production/control of biologicals with sound scientific understanding of products and processes
  • Several years’ experience in global CMC regulatory for biologicals and drug-device combination products, Experience in Antibody‑Drug Conjugate (ADCs) would be an advantage
  • In-depth knowledge of international CMC regulatory requirements, including ICH, FDA, PMDA, EU and emerging markets
  • Track record of leading strategic initiatives and driving regulatory strategy
  • Proven ability to lead and motivate people in cross-functional teams, set direction and manage changes
  • Inter-disciplinary mindset combined with innovative and strategic thinking
  • Team player with excellent organizational and communication skills, including strong prioritization and time management capabilities
  • Fluency in English (written and spoken); German language skills are an asset

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 April 16, 2026. We reserve the right to take the posting offline beforehand. Applications up to April 2, 2026 are guaranteed to be considered.
Step 2: Virtual meeting till end of April
Step 3: On-site interviews beginning of May

Please submit your application documents in English.

Discover our Biberach site: xplorebiberach.com

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