Director of Regulatory Services
3 weeks ago
TMC- who are we?
TMC Pharma Services Ltd, located in Hartley Wintney, provides a full range of expert support services to the pharmaceutical industry. Our highly qualified team specialises 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/hybrid role for a Director of Regulatory Services based in our stunning headquarters in Hartley Wintney, Hampshire. As a Director of Regulatory Services, you will be responsible for overseeing regulatory activities, 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. You will get the opportunity to work on a wide range of regulatory activities in some very interesting disease/treatment areas, and to further develop your skills.
Qualifications
- Strong knowledge of regulatory affairs, regulatory requirements, and regulatory compliance
- Hands on 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 organisational and time management skills
- Experience in the pharmaceutical/pharmaceutical service industry is required
- Bachelor's degree in a related field
- Advanced degree in a related field is a plus
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