Summary
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.
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Adjustments for Applicants with Disabilities
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
