Global Regulatory Specialist

1 week ago


London, Greater London, United Kingdom CV Library Full time

Job Title: Global Regulatory Specialist

About the Company:

CV Library is a leading provider of career opportunities in the pharmaceutical industry. We are committed to delivering high-quality services to our clients and candidates.

About the Role:

We are seeking a highly skilled Global Regulatory Specialist to join our team. As a key member of our regulatory team, you will be responsible for managing CMC regulatory activities for a small molecule oncology product globally. This is a contract position until the end of March 2025, with a strong likelihood of extension for a further 6-month period.

The successful candidate will have over 10 years of experience in CMC technical roles, with at least 5 years in lifecycle management of small molecule products. They will also have experience in pre- and post-approval CMC regulatory activities, effective stakeholder management, project management within a CMC context, and knowledge of IND/NDA and IMPD/MAA formats.

Key Responsibilities:

  1. Change control procedures
  2. Out of specification management
  3. CMC commitments and variation submissions
  4. Product Quality Review (PQR) production and review
  5. Collaboration with external CMOs
  6. Manage CMC regulatory activities for clinical programs, including:
    1. Authoring INDs and IMPDs
    2. Responding to Health Authorities
    3. Preparing documents for QP release
    4. Post-submission management
Requirements:
  • Over 10 years in CMC technical roles, with at least 5 years in lifecycle management of small molecule products
  • Experience in pre- and post-approval CMC regulatory activities
  • Effective stakeholder management
  • Project management within a CMC context
  • Knowledge of IND/NDA and IMPD/MAA formats
  • Understanding of drug substance and product CMC
  • Organized, independent, and able to manage multiple activities
  • Degree in Pharmacy or a relevant science/technical subject
  • Skills: Proficient in English, French is an advantage
Benefits:
  • Opportunity to work on a global project
  • Chance to develop skills in CMC regulatory activities
  • Professional growth opportunities
  • Competitive salary


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