
Senior Regulatory Lead
6 hours ago
We are seeking an experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences.
Key Responsibilities:
- Provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.
- Develop and implement effective regulatory strategies to support drug development activities.
- Prepare and submit regulatory documents, including orphan drug designation applications and clinical trial authorizations.
- Cultivate strong relationships with regulatory authorities to ensure successful project outcomes.
About the Role:
- This is a leadership position that requires a minimum of 12+ years of experience in Regulatory Affairs within a complex therapeutic area.
- The ideal candidate will have extensive experience in early-stage drug development and be confident with UK, EU, and US health authorities and drug pathways.
- A strong understanding of EMA procedures and ability to drive global Regulatory Affairs Strategies are essential.
- The salary for this role is estimated to be £130,000 + Benefits, reflecting the importance of this position in our organization.
Benefits:
- A competitive salary package, including benefits and bonuses.
- The opportunity to work with a prestigious global drug development consultancy business.
- A dynamic and collaborative work environment.
Requirements:
- A B.Sc. in a life sciences subject and/or a higher degree preferably a PhD but this isn't essential.
- Excellent written and verbal communication skills.
- Able to negotiate and concisely express clear positions to stakeholders at all levels.
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