Director of Regulatory Affairs

4 weeks ago

Hartley Wintney Hampshire, United Kingdom TMC Pharma Services Ltd Full time

Company Description

TMC Pharma Services Ltd, located in Hartley Wintney, provides a full range of expert support services to the pharmaceutical industry. Our highly qualified team specializes in drug development from preclinical to post approval, regulatory affairs, drug development consultancy, and post approval/marketing support. We are known for our hands-on problem-solving approach and enjoy tackling the unique challenges that each project brings. Our clients span the pharmaceutical industry in Europe, the USA, and beyond, ranging from biotech start-ups to blue-chip multinationals.

Role Description

This is a full-time on-site role for a Director of Regulatory Affairs based in our stunning headquarters in Hartley Wintney, Hampshire . As a Director of Regulatory Affairs, you will be responsible for overseeing regulatory compliance, ensuring adherence to regulatory requirements, managing regulatory submissions, and maintaining a quality system. You will work closely with cross-functional teams to develop and execute regulatory strategies and provide guidance on regulatory matters. Ideally you will have hands on experience of oversight of dossier preparation, MAA/NDA/BLA submissions and post approval/lifecycle maintenance. Experience in authoring or oversight of paediatric investigational plans, scientific advice, orphan drug designations, agency meetings and IND/clinical trial submissions would also be valuable.

Qualifications

  • Strong knowledge of regulatory compliance, regulatory requirements, and regulatory affairs
  • Experience in managing regulatory submissions
  • Familiarity with quality systems
  • Excellent analytical and problem-solving skills
  • Ability to work effectively in cross-functional teams
  • Exceptional attention to detail
  • Excellent written and verbal communication skills
  • Strong organizational and time management skills
  • Experience in the pharmaceutical industry is highly preferred
  • Bachelor's degree in a related field
  • Advanced degree in a related field is a plus

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