Regulatory Affairs Lead Position
3 days ago
We are seeking an experienced Regulatory Affairs Lead to join our team at Blackfield Associates. As a Senior Regulatory Affairs Manager, you will play a key role in driving our EU licensing efforts and shaping regulatory strategies.
About the Job
- You will be responsible for leading the development and implementation of regulatory strategies during product development, approval, and lifecycle management.
- This includes collaborating with regulatory authorities to ensure compliance with EU regulations and guidelines.
- Additionally, you will support Clinical Trial Applications under the new Clinical Trials Regulation and register new medicinal products in the EU.
Your Skills and Experience
- A degree in a relevant scientific discipline is essential for this role.
- You will have extensive experience with Clinical Trial Applications in the EU and European-wide regulatory procedures.
- Proven leadership skills, having led teams or had direct reports previously.
- Familiarity with Immunology, Oncology, Gastroenterology, or Respiratory therapeutic areas is necessary, as well as knowledge of Medical Device regulations, which would be advantageous.
What We Offer
- A competitive salary of £65,000 - £90,000 per annum.
- A permanent position with hybrid working arrangements, based at our Slough European HQ.
- A weekly office presence is required, and applicants must hold a valid right to work in the UK, with no sponsorship available.
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