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
Employment Type
Full-time