Maintaining close cooperation with RA CMC to discuss regulatory requirements, strategies and knowledge of global product dossiers to stay up-to-date.
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 products and customer products.
Contact person for regulatory matters and intermediary between RA CMC and production unit at strategy decisions and in the product life cycle.
Support of timely reviews of CMC documents for defined products; Support with and Identification of challenges in the course of regulatory compliance audits.
Implementation and overview of initiatives to improve (regulatory) compliance.
Coordination, guidance, and support in the preparation of CMC responses to health authorities for specific products.
Essential Requirements:
Advanced University or academic degree in chemistry, biology, pharmacy, engineering 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 substance manufacturing processes for recombinant proteins and/or nucleic acids.
Ability to speak up and to take Quality decisions during challenging situations.
Desirable Requirements:
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.
