CMC Regulatory Manager

CMC Regulatory Manager

Bavarian Nordic

Munich, Germany

You will be responsible for leading CMC regulatory submission for current and future oncology and Infectious Diseases programmes, ensuring that regulatory documents are in compliance with health authority regulations and interact with international health authorities and commercial partners.

Reporting to a Senior Director, CMC Regulatory Affairs, your main responsibilities will be as listed below. You will be supporting or driving activities, depending on your level of experience:

Duties and Responsibilities

  • Provide CMC regulatory advice to subject matter expects (Global Operations, Quality and R&D) based on current regulatory guidance;
  • Develop timelines for CMC submissions and follow up with subject matter experts (Global Operations, Quality, R&D) to ensure timely and quality submissions;
  • Develop and/or review regulatory documents to ensure that all submissions are of high quality;
  • Participate in the development of regulatory strategies and provide strategic input and regulatory advice to the project teams on development programs;
  • Review and provide regulatory assessment to proposed CMC changes;
  • Lead the preparation of responses to questions from Regulatory Authorities;
  • Support the preparation and conduct of Agency meetings, including preparation and coordination of briefing packages;
  • Maintain knowledge of current global rules, regulations, and guidance governing development of drugs and biologics in all phases of development.

Your Profile

  • B.S. in scientific discipline, advanced degree preferred (M.S., Ph.D.);
  • 5-10 years of work experience in the pharmaceutical or biotech industry, preferably in the area of Regulatory CMC and/or Manufacturing/Quality Control/Quality Assurance. Minimum of 3+ years in CMC regulatory is preferred;
  • Proven ability to effectively work on interdisciplinary and cross functional teams;
  • Strong attention to detail along with written and verbal English communication skills required;
  • +40 days/year of travelling is expected.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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