Regulatory Affairs Director
4 weeks ago
**Regulatory Affairs Director Role Overview**
Cpl Life Sciences is seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy and drive business growth.
As a key member of our team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations and guidelines.
**Key Responsibilities:**
- Develop and implement regulatory strategies to support business growth and ensure compliance with global regulations and guidelines.
- Lead regulatory agency interactions/negotiations to ensure client goals are met.
- Prepare regulatory submission documents, including orphan drug designation applications, scientific advice briefing documents, and Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications.
- Provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives, and early market access.
**Requirements:**
- At least 10 years of industry experience in a regulatory role.
- Prior experience in a CRO/pharmaceutical environment.
- Extensive experience driving global regulatory strategies.
**What We Offer:**
- A competitive salary and benefits package.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
If you are a highly motivated and experienced Regulatory Affairs Director looking for a new challenge, please submit your application.
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