RA CMC Manager

Posted 30 January 2023
Job type Permanent
Contact NameDavid Skinner

Job description


Key Responsibilities
  • Responsibility for the lifecycle management (LCM), including market expansions, of vaccines
  • Lead the regulatory submission strategy, identify submission risks and opportunities and execute through to approval
  • Provide CMC regulatory advice to subject matter experts based on current regulatory guidance and sound scientific rationales
  • Provide regulatory assessment to proposed CMC changes
  • Lead the preparation of responses to questions from Regulatory Authorities for your area of responsibility
  • Support the preparation and conduct of Agency meetings

  • Degree within life sciences, preferably M. Sc. in chemistry or pharmacy, Ph.D. or similar
  • Relevant experience (5-8 years) within the pharmaceutical or biotech industry, specifically within CMC regulatory affairs from a global perspective or a regulatory agency
  • Background in vaccines is preferred
  • Experience liaising with regulatory agencies
  • In-depth knowledge of current global rules, regulations and guidance governing Regulatory LCM of drugs and biologics
  • Fluent in English

Who are you?

You possess the ability to communicator clearly and succinctly with a variety of stakeholders and are comfortable asserting your professional opinion when needed. Comfortable in your RA expertise, you look at the bigger picture and can lead a cross-functional project to success.