Regulatory Affairs Strategic Lead
2 days ago
Estimated salary: £80,000 - £100,000 per annum.
About Clinical Professionals LimitedWe are a leading provider of pharmaceutical and biotechnology expertise, supporting the translation of science into medicinal products. Our team is passionate about delivering high-quality services that meet the needs of our clients.
Job DescriptionAs an Associate Director, Regulatory Affairs, you will play a key role in leading regulatory strategies for development programs globally. You will be responsible for providing strategic regulatory advice, preparing regulatory submission documents, and leading regulatory agency interactions.
- Lead client projects, providing strategic regulatory advice while considering regulatory guidelines and measures to facilitate regulatory input, incentives, and early market access.
- Prepare regulatory submission documents, including orphan drug designation applications, scientific advice briefing documents, Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications, Paediatric Investigation Plans (PIPs)/Pediatric Study Plans (PSPs), PRIME/Breakthrough Therapy or Regenerative Medicines Advanced Therapy Designation (BTD/RMAT) applications.
- Lead regulatory agency interactions/negotiations to ensure client goals are met.
To succeed in this role, you will require at least 10 years of industry experience in a regulatory role, with prior experience in a CRO/pharmaceutical environment and extensive experience driving global regulatory strategies.
BenefitsThis role offers a competitive salary, excellent benefits package, and opportunities for professional growth and development. If you are a motivated and experienced regulatory affairs professional looking for a new challenge, we encourage you to apply.
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