(Senior) Manager Global Regulatory Affairs CMC (m/f/x) | Frankfurt | Pharma
In this role, you will be playing a key role with your specific knowledge on regulatory quality requirements for the approval of medicinal products. You will produce and update high quality CMC (Chemistry-Manufacturing-Control) documentation with the aim of obtaining Foundational Products approvals. Additionally, ensure that CMC marketing authorization documentation complies with current regulatory requirements and current manufacturing.
What will your tasks as "(Senior) Manager Global Regulatory Affairs CMC" be?
- Preparation and updating of CMC documentation for international purposes
- Preparation of regulatory assessments on changes in the CMC section
- Responding to enquiries from authorities regarding CMC topics
- Participation in international maintenance teams
- Contact person in the CMC area
- Ensuring efficient risk and product management
- Collaboration in the evaluation of CMC documents within the scope of due diligence activities
Your requirements as "(Senior) Manager Global Regulatory Affairs CMC"?
- Degree in natural sciences, preferably pharmacy, chemistry, or biology
- 3-5+ years of professional experience in a hands-on CMC documentation role
- Comprehensive knowledge of regulatory guidelines and formal requirements of CMC activities, knowledge of combination products or medical devices is a plus
- Very good knowledge of English, German or another foreign language would be a plus
- An analytical and structured way of working with a strong attention to detail and strong organizational skills plus the ability to work in a team
Information about our client :
Our client is a leading pharmaceuticals & medical devices companies in Europe. The company is more than 100 years old and it's more than 3000 employees are operating in 50+ countries. The diverse specialties of the company include medical aesthetics and neurotoxin therapy. The company is also active in research, development, and distribution of further innovative products (innovative health, wellness and beauty).
I look forward to your application!