Regulatory Affairs Manager
£50,000 – £60,000 + Benefits
Opportunity to join a leading pharmaceutical business based in the Liverpool region. This organisation work across a range of industries including medical devices, pharmaceutical and packaging. The role of Regulatory Affairs Manager is a key contributor role offering strategic advice for global submissions, particularly for the Emerging Markets.
- Manage regulatory agency communication to expedite approvals.
- Product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
- Ensuring timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
- Support CMC regulatory activities for pipeline products.
- Ensure that Marketing Authorisations are maintained and renewed.
- Experience in the preparation and maintenance of CMC components for regulatory submissions.
- Solid understanding in developing Regulatory requirements, such as IDMP, XEVMPD for Regulatory Product data tracking, registration, eCTD for Publishing, SPL for Labelling IT Solutions.
- Thorough understanding of FDA (21CFR 210, 211, 820 and EU regulations.
- BSc / Master’s degree in Life Sciences or other science / engineering related discipline.
As Regulatory Affairs Manager you’ll receive a highly competitive salary, up to 15% pension, annual bonus and relocation assistance.
To apply for this role, please click Apply button, or contact Gareth Wrigley at Pulse Engineering Solutions. All applications are received in the strictest confidence.