Regulatory Affairs Cmc Senior Manager

vor 2 Wochen

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
**About the Role**:
**Major accountabilities**:

- Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for XXX modality projects/products.
- Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
- Lead, prepare and communicate CMC risk management assessments and lessons learned on major submissions.
- Initiate and lead Health Authority interactions and negotiations.

Minimum Requirements:

- Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired
- Minimum 5 years of regulatory CMC experience and/or pharmaceutical industry experience
- Demonstrated knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements
- Proven ability to critically evaluate data from a broad range of scientific disciplines

Division

Development

Business Unit

Pharmaceuticals

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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