Technical Regulatory Lead
Skills Alliance is partnered with a leading pharmaceutical & medical device company, translating pioneering science into vision-saving treatments to hire their Technical Regulatory Lead (Life Cycle Management focus ). The company is supported by a strong, global team who aim to harness the potential of ophthalmic medicine to deliver new treatments to all ocular disease patients as quickly as possible.
The Technical Regulatory Lead will hold responsibility for the creation and maintenance of technical-regulatory files to contribute to obtaining, maintaining, and extending Marketing Authorisations (MA), with a particular focus on existing products/extensions. The position involves close collaboration with various function leads to ensure full compliance with current health authority regulations.
Desired Skills & Experience
- University Degree, Scientific Discipline preferred
- Deep experience in the creation and submission of marketing authorisation dossiers
- Experience working on sterile products, with knowledge of sterilisation/aseptic requirements
- Experienced across active ingredients and drugs
- Submitted dossiers globally, experience engaging with health authorities (FDA & EMA)
- Strong collaborator, technically proficient