Sr Manager Global Regulatory Affairs CMC (biotech) (m/f)

☞ Merck Group

View: 186

Update day: 25-03-2024

Location: Aubonne Vaud VD

Category: Production / Operation Planning / Projects Science Labor

Industry: Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

Your role:You are responsible for driving all CMC Regulatory activities for assigned large molecules (biotech) commercial products and projects worldwide. In this role you develop, author and own the relevant Global Regulatory CMC Life Cycle Strategy and all CMC Dossier types, such as NDAs/MAAs, variations, amendments, renewals, annual reports, and answers to health authority questions.

You serve as the contact point for CMC Regulatory topics and act as liaison in-between technical CMC-, quality-, supply- and Regulatory Affairs functions and provide strategic support and advice to the CMC team, the Global Regulatory Strategy Team (GRST), the Global Product Supply Team (GPST), and other cross-functional project teams (e.g. Tech Transfer Project Team). Upon collecting and interpreting country-specific regulatory CMC requirements you translate them into deliverables. You plan and align CMC Regulatory activities and develop submission roll-out and implementation plans, in close collaboration with key stakeholders.

You are the expert for CMC regulations, guidance, regulatory trends and competitive environment, including accelerated pathways, and CMC innovations and lead and participate in internal and cross-functional, international initiatives.



Who you are:

  • University degree in Life Sciences such as Biochemistry, Biotechnology or a related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
  • Min. 5 years of CMC regulatory and/or CMC technical experience within the pharmaceutical / biotech industry (e.g. in global regulatory affairs, quality control, analytical development or manufacturing / process development)
  • Ability to develop and prepare successful regulatory CMC strategies for variations, renewals, or new registrations (new MAAs, NDAs)
  • Experience in preparation and management of regulatory CMC documentation for new drug applications or complex variations
  • Sound understanding and in-depth knowledge of global pharmaceutical legislation
  • Excellent written and spoken communication skills in English (knowledge of other European languages such as French, Italian or German is an asset)





What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!



Curious? Apply and find more information at https://jobs.vibrantm.com

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Deadline: 09-05-2024

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