Regulatory CMC Manager | Chemiker/in
Novartis Pharmaceutical Manufacturing GmbH
Job Summary
As a Regulatory Chemistry, Manufacturing, and Controls (CMC) Manager at Novartis, you will lead global regulatory strategies for innovative Cell & Gene Therapy projects. Your daily responsibilities involve planning, authoring, and reviewing high-quality technical documentation for Health Authority submissions to support both new product launches and post-marketing activities. You will act as a key liaison, negotiating with Health Authorities and collaborating with cross-functional project teams to ensure regulatory compliance and technical congruency. This role is particularly attractive for professionals looking to work at the forefront of medical innovation in a hybrid setting, offering a competitive salary and the opportunity to manage complex risk assessments and life cycle maintenance within a world-leading pharmaceutical group.
Required Skills
Education
Science degree in Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology, or an equivalent qualification.
Experience
- At least 2 years of experience in regulatory CMC or the pharmaceutical industry
- Demonstrated working knowledge of chemistry, biotechnology, analytics, or pharmaceutical technology
- Experience in managing regulations, guidelines, and product life cycle maintenance
- Proven ability to critically evaluate data from a broad range of scientific disciplines
Languages
Additional
- Location: Schaftenau, Austria; Hybrid work model; Full-time permanent contract.
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