CMC Regulatory Affairs Manager (m/f/x) | Munich | Pharma
Our client, a radiopharmaceutical biotech company, provides patients, physicians and partners with high-precision radiotherapeutics and diagnostics to fight cancer. They are always motivated by their commitment to the best interests of patients, for which high-quality products have been developed, produced, and made globally available. With almost two years of experience in the radiopharmaceutical field and the global supply network, the company aims to fully exploit the great potential of nuclear medicine to help patients live longer and better.
What will your tasks as CMC Regulatory Affairs Manager be?
- Preparation of IMPD, IND and Briefing Board
- Conception, specifications and support of product developments
- Supervision of the planning and cross-departmental coordination of approval-relevant work packages and clinical studies
- Participation and coordination of regulatory submissions, lifecycle management
- Responsible for the strategy, compilation and maintenance of CMC approval documents
- Representation of Manufacturing and Controls (CMC) expertise in product development, key customer and cross-departmental projects
- Bachelor/master's in pharmacy, chemistry, biochemistry, biotechnology
- At least 5 years of experience in CMC
- depth experience of drug regulatory requirements and GMP
- Professional experience with biologicals and radiopharmaceuticals
Essential knowledge & skills:
- Excellent written and communication skills in English and German
- Demonstrated teamwork and working in a multidisciplinary matrix setting
My contact details:
- Email: firstname.lastname@example.org
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
- Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
- LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/
I look forward to your application!