An opportunity has arisen for a Regulatory Affairs Manager to join the Regulatory and Clinical Affairs team. The role will be responsible for providing comprehensive and broad-ranging regulatory expertise and management in all aspects of obtaining and maintaining market authorisations and other regulatory registrations/permits required by the Group.
The role will include but not be limited to the following:
- Providing regulatory strategy expertise in NPD and product maintenance.
- Providing regulatory support to clinical development.
- Regulatory compliance guidance and support to other departments with a particular focus on CMC.
- Developing constructive relationships with Regulatory Authorities, Notified Bodies, contract manufacturers and business partners.
- Planning, organising and as necessary compiling and submitting applications for clinical trials, marketing authorisations/registrations/technical files, manufacturing authorisations and wholesale dealer’s authorisations.
- Preparing and submitting variation, renewal and labelling change applications to maintain product licences, device registrations and technical files.
- Preparing and maintaining additional supporting regulatory documentation including product literature and technical reports.
- Assisting in reviewing labelling, and advertising copy in accordance with regulatory standards.
- Managing, motivating, training and developing the regulatory team.
- Several years relevant regulatory experience in medicines and preferably also in medical devices and/or cosmetics.
- Experience in CMC is essential as there is a significant emphasis on technical aspects in this role.
- Ability to identify commercially effective approaches to regulatory problems and find innovative solutions.
- Strong organisational and planning skills.
- Excellent verbal and written communication skills, with the ability to present complex issues in a clear, logical and persuasive way.
- Computer competence and experience of document management systems and NeeS/eCTD submission.
- Meticulous attention to detail.