Hybrid Senior Manager, GRA CMC Vx Mature Product

Posted 2 weeks ago

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About the role

  • Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with global standards.
  • Prepare and review technical regulatory documents to support submissions and lifecycle management.
  • Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance.
  • Lead discussions with regulatory authorities and represent the company in external engagements.
  • Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
  • Mentor and train team members, fostering a culture of continuous improvement.

Requirements

  • Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field
  • Solid and proven experience in CMC regulatory affairs
  • Strong knowledge of global CMC regulatory requirements and drug development processes
  • Proven ability to manage multiple projects and meet deadlines
  • Must be fluent in English (both written and spoken)
  • Master’s degree or PhD in a relevant scientific discipline (preferred)
  • Regulatory Affairs Certification (e.g., RAPS) (preferred)
  • Experience leading teams and managing complex regulatory submissions (preferred)
  • Track record of effective negotiation with regulatory agencies (preferred)
  • Excellent communication and collaboration skills (preferred)
  • Proficiency in French is a plus (preferred)

Benefits

  • Permanent contract in a very Inclusive environment
  • Smart Working up to 50% for eligible roles
  • Performance Reward
  • Flexible Benefits
  • Company Healthcare Plan
  • Integrative pension fund
  • Employee Assistance Programme
  • Prevention services and vaccination clinic
  • Tax assistance
  • Local nursery agreement
  • Postal service, laundry, shoe repair and tailoring
  • On Site Gym
  • On Site canteens and coffee corners
  • Free company bikes and shuttle

Job title

Senior Manager, GRA CMC Vx Mature Product

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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