Summary
Supporting product registration and maintenance throughout the product life cycle by aligning regulatory strategies and reviewing documents related to CMC (Chemistry, Manufacturing & Control). This applies to site specific (global and local) products and is intended to ensure timely market supply in compliance with regulatory requirements. Supporting change control and inspection management within the QA Compliance Team.
About the Role
Key Responsibilities:
- Contact person for regulatory matters and intermediary between RA CMC and production unit for strategy decisions and in the product life cycle.
- Maintaining close cooperation with RA CMC to discuss regulatory requirements, strategies and knowledge of global product dossiers to stay up-to-date.
- Support of timely reviews of CMC documents for defined products; Support with and identification of challenges in the course of regulatory compliance audits.
- Coordination, guidance, and support in the preparation of CMC responses to health authorities for specific products.
- Conducting training to ensure appropriate knowledge and regulatory compliance.
- Supporting the area in effective change control. Examination of reg. relevance and pre-evaluation amendments to Novartis and customer products.
- Implementation and overview of initiatives to improve (regulatory) compliance.
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Essential Requirements:
- University or academic degree in chemistry, biology, pharmacy, biotechnology or equivalent.
- Fluent English (German desired).
- More than 3 years of experience in an operational GxP area, in Manufacturing, Development or QA or Regulatory Affairs; with a thorough knowledge of biologic drug product manufacturing processes.
- Ability to speak up and to take Quality decisions during challenging situations.
Desirable Requirements:
- Regulatory CMC experience preferred
- Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership, and project management experience.
- Ability to work independently and effectively in international, complex, and multifaceted environments.
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Division
Operations
Business Unit
Innovative Medicines
Location
Austria
Site
Schaftenau
Company / Legal Entity
AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No