Manager, Regulatory Affairs Pharma

Manager, Regulatory Affairs Pharma

dsm-firmenich

Kaiseraugst, Switzerland

Your key responsibilities:

• Lead the joint efforts for the development of the global API product approval strategy for food and pharma products in a timely and accurate manner.
• Manage and support the food and pharma submissions (i.e. new registrations, renewals of authorizations or line extensions) in certain regions or countries.
• Dossier preparation (e.g. DMFs, CEPs, Core Dossiers) and support for product approval in collaboration with R&D, Product and Project Management, global and regional Regulatory Affairs (RA) based on the global RA strategies of dsm-firmenich. Coordinate the submission of dossiers to the regional authorities and follow up on the approval process.
• Work with Product Management and production sites to ensure regulatory compliance of dsm-firmenich products.
• Monitor and report modification of the changing regulatory framework and environment, and assess their impact on the business.
• Lead the development of dsm-firmenich opinions in the area of RA.
• Develop SOPs, work on and/or select appropriate regulatory platforms & applications (software solutions), as appropriate to specific issues.
• Contribute to the development and maintenance of registration status & planning platforms. Highly contribute to the RA team performance by taking leadership in development and maintenance of efficient RA tools, processes and coaching of employees and junior colleagues, as applicable.
• Support Total Quality Management for the product-specific aspects (e.g. specifications) in customer quality agreements, as needed.
• Support issue management related to product quality, e.g. impurity complaints, in close cooperation with all internal functions (e.g., QA, Marketing & Sales, Product Management) and represent Regulatory Affairs.
• Responsible for global or regional representation, networking and shaping activities, where applicable.
• Support for global standard product document creation, update and maintenance.

You bring:

• University degree in chemistry or natural sciences life sciences, or equivalent.
• At least 7 years of experience in Regulatory Affairs and/or Quality Management/Production background, preferably in Vitamins and APIs.
• Experienced/skilled in use of related regulatory IT platforms & applications such as Veeva RIMS, Documentum, Trackwise.
• Strong persuasive personality, but able to balance and compromise different opinions.
• Strategic and solution-thinking skills.
• Precise working style, persistence in pursuing objectives.
• Open-minded, good team working and solution-thinking skills; cross-functional collaboration skills are a must.
• Ability to assess, manage and communicate regulatory risks for given submissions or situations.
• Fluent in written and spoken English; German and any other language an asset.