The Regulatory Affairs Team Lead will be responsible for leading the Regulatory Affairs submission team and coordinate team workload and activities while managing the lifecycle of the medicinal products across Europe.
- The Regulatory Affairs Team Lead will lead preparation of Module 1 documentation, ensure submissions and deficiency questions are properly handled and in timely manner with regards to new applications, renewal and variation procedures
- You will be responsible for monitoring new legislations and train concerns internal stakeholders
- Liaise with external parties, Health Authorities of EU, customers and contract manufacturers
- The Regulatory Affairs Team Lead will provide support to non-EU clients registration procedures, from due diligence to lifecycle activities
As the Regulatory Affairs Team Lead, you should have 6 years of pharmaceutical industry experience including at least 2 years as a manager. You should also have an in-depth knowledge of EU regulatory requirements with focus on eCTD submissions
If you're looking to join a company offering excellent career progression opportunities then send your CV now. There is an excellent remuneration package on offer and the option to work remotely full time.
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