24 days ago
Hamlyn Williams has partnered with a rapidly expanding biopharmaceutical company based in Germany. This global biopharmaceutical firm is currently in a major phase of growth due to its innovative and expansive pipeline, and are looking for a Senior Regulatory Affairs Manager on a permanent basis.
The role will involve but not be limited to:
- European regulatory strategy support for projects, covering development plans, clinical trials, and Marketing Authorizations Applications as well as product life cycle management.
- European Regulatory Affairs representation on global development teams providing regulatory guidance and strategy and supporting EU MAA submissions
- Act as regulatory contact person for authorities
- Review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders
As a Senior Regulatory Affairs Manager you will need:
- Experience in the pharmaceutical industry, with 5 years within global regulatory affairs with emphasis on late stage drug development and marketing authorization applications in Europe, experience with clinical trials
- Experience of working in a global environment
- The ability to plan, coordinate and lead activities
- The ability to develop as well as maintaining positive relationships, challenge viewpoints, present and put cases forward in a professional and polite manner
- Excellent written and oral communication skills in English
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.