16 days ago
Hamlyn Williams has partnered with a rapidly expanding biopharmaceutical company based in Frankfurt. This global biopharmaceutical firm is currently in a major phase of growth due to its innovative and expansive pipeline, and are looking for a Regulatory Affairs Manager on a permanent basis.
The role will involve but not be limited to:
- Providing strategic regulatory guidance, developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions.
- Be the primary contact to the relevant authorities within Europe and other regions when required
- Obtain regulatory intelligence, research precedent approvals and former decisions made by the health authorities
- Translate the complex global requirements and provide an assessment of the associated regulatory challenges to the relevant stakeholders
- Lead cross functional teams to develop a regulatory plan, address the global regulatory challenges and issues, respond to the health authorities questions and queries, and meet all appropriate regulatory requirements
- Provide oversight to outsourced suppliers of regulatory support in preparation of documentation and reports.
As a Regulatory Affairs Manager you will need:
- Comprehensive knowledge of the drug development process, drug laws, global regulations and guidelines
- Experience in leading the submissions of CTA, IND, sNDA/ NDA, MAA and Variations
- Experience in working in, and communicating with cross-functional project teams involving internal and external experts
I am a Quality Assurance and Regulatory Affairs market specialist working with a large variety of clients across the pharmaceutical and biotechnology industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Sonny at +44 020 8164 5340 or at email@example.com.