Regulatory Affairs Cmc Associate Director

vor 2 Wochen

Langkampfen T, Österreich Novartis Vollzeit

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

- Formulate, lead and drive global CMC regulatory strategy for XXX modality pro-jects/products drawing on substantial regulatory expertise with a focus on innovation, maxim-izing the business benefit balanced with regulatory risks and compliance.
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders
- Initiate and lead Health Authority interactions and negotiations: setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA.
- Provide strategic advice and direction within the department and cross-functionally through specialized assignments.

**Minimum Requirements**:
Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biol-ogy, Biotechnology, Biology) or equivalent; advanced degree desired
- Minimum 8 years regulatory experience preferred and/or pharmaceutical industry experience
- Substantial 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.

**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

**Join our Novartis Network**:
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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