RA CMC Manager (Part time 0.5 FTE for 24 months)

Job ID: REQ-10060562
Datum: Sep 10, 2025
Land: Austria (Österreich)
Site: Schaftenau (Tirol)
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Job Type: Part time (0.5 FTE)
Employment Type: Temporary (Fixed Term, 24 months)
Shift Work: No

Summary

As manager, you provide strategic and operational global CMC regulatory direction and documentation for products across development and post-approval activities.

Major accountabilities

Formulate and lead global CMC regulatory strategy for Biologics and Small Molecules.
Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission).
Identify required documentation; resolve content/quality/timeline issues; negotiate delivery of approved technical source documents.
Author/review high-quality CMC documentation for Health Authority submissions; ensure regulatory compliance, timelines and e-publishing requirements.
Communicate CMC strategies, risks and key issues; represent the department in cross-functional project teams.
Prepare and communicate CMC risk assessments and lessons learned on major submissions.
Initiate and lead Health Authority interactions and negotiations.

Minimum requirements

Science degree (e.g., Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology); advanced degree desired.
Ideally ≥2 years regulatory CMC and/or pharmaceutical industry experience; working knowledge in regulatory submissions desirable.
Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology; knowledge of regulations/guidelines and product life cycle maintenance desirable.
Ability to critically evaluate data from a broad range of scientific disciplines.

Benefits & Rewards

Market-competitive base salary, attractive incentive program, modern company pension scheme, childcare facilities, learning and development opportunities, global career possibilities.

AT salary disclosure: Minimum EUR 63,600/year (full-time basis) as per collective agreement. Actual pay significantly higher depending on experience and qualifications.

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More information

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Accessibility

Adjustments for applicants with disabilities: disabilities.austria@novartis.com

RA CMC Manager (Part time 0.5 FTE for 24 months)

Novartis Pharma GmbH

RA CMC Manager (Part time 0.5 FTE for 24 months)

RA CMC Manager (Part time 0.5 FTE for 24 months)

Hauptstandort

Novartis Pharma GmbH

Novartis Pharma GmbH

Hauptstandort

pharmakarriere.at

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