(Senior) Manager Regulatory Affairs CMC (m/f/x) | Stuttgart area / remote
In this position you will be mainly responsible for managing CMC regulatory aspects of projects including overseeing preparation and submission of CMC submissions (module 2.3 & 3) in the phase of development. You will be managing interactions with authorities for assigned projects, maintain awareness of and expertise in ICH, FDA and EU guidelines and coordinate and collaborate in creating high-quality regulatory documents.
What will your tasks as "(Senior) Manager Regulatory Affairs CMC (m/f/x)" be?
- Proactively manages regulatory CMC aspects of projects including overseeing preparation and submission of CMC submissions appropriate to the phase of development
- Coordinates and collaborates in creating high-quality regulatory documents (e.g. CMC sections of briefing books for health authority interactions, IMPDs, INDs) in close collaboration with the individual CMC functions
- Manages interactions with regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments/supplements/variations, and other submissions which contain CMC information.
- Maintains awareness of and expertise in ICH, FDA and EU guidelines related to CMC regulatory topics with a focus on biopharmaceuticals
- Incorporates regulatory requirements in pre-clinical and clinical development
- Develops and maintains excellent relationships with regulatory authorities, internal functional groups, and corporate partners
Your requirements as "(Senior) Manager Regulatory Affairs CMC (m/f/x)"?
- Degree in natural sciences, biotechnology, pharmacy, veterinary medicine or medicine; advanced degree would be a plus
- 2+ years experience with CMC in pharmaceutical industry; preferably in biopharmaceuticals and regulatory affairs
- Knowledge of ICH-CMC regulatory requirements for biopharmaceuticals and ability to apply knowledge both strategically and operationally
- Elementary understanding of EMA, FDA and international CMC regulations
- Strategic mindset, innovative yet pragmatic/solution-oriented thinking, and attention to detail with a strong orientation to quality
- Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities.
- Business-fluent written and spoken in English; good level of German would be desired
Information about our client:
Our client is a globally operating clinical-stage biopharmaceutical company researching and developing drugs. With their team of around 1000 people, their focus is on vaccines, innovative cancer immunotherapies and protein-based therapies.
I look forward to your application!