CMC Regulatory Manager (m/f/d)

  • 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
  • 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

» Job description

Bavarian Nordic GmbH
82152 Planegg-Martinsried