Regulatory Affairs Manager Apis

vor 7 Monaten

Kaiseraugst, Schweiz DSM-Firmenich Vollzeit

As the Global Regulatory Affairs Manager for APIs, you will be part of a cross-functional team, based in Kaiseraugst, Switzerland. The activities linked to the position are highly complex due to the dynamics of the global market and changing regulatory environments. Your responsibility will encompass the integration of the Marketing and Sales, plans into your regulatory strategy program and its global roll out in cooperation with the regional teams. You will be part of a highly professional and motivated team.

At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.

**Key areas of responsibility**
- Lead the joint efforts for the development of the global product approval strategy for feed, food and also pharma in a timely and accurate manner.
- Manage and support the food and feed 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 based on the global Regulatory Affairs strategies of DNP. 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 DNP products.
- Monitor and report modification of the changing regulatory framework and environment, and assess their impact on the business
- Lead the development of DSM opinions around Regulatory Affairs
- Contribute to the development and maintenance of registration status & planning platforms. Highly contribute to the Regulatory Affairs team performance by taking leadership in development and maintenance of efficient RA tools (e.g. DSM store) processes and coaching of employees and junior colleagues.
- 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 PIB document creation, update and maintenance.

**We bring**
- A hybrid workplace that offers flexibility to employees across the business.
- The chance to shape DSM and its impact for years to come.
- Diverse employees who aren’t afraid to think outside of the box.
- A team that truly cares about sustainability, each other, and our customers.
- A supportive environment where you’re empowered to grow and share your ideas.

**You bring**
- University degree in chemistry or natural sciences life sciences.
- At least 5-8 years of experience in Regulatory Affairs and/or Quality Management/Production background, preferably in Vitamins and APIs.
- Strong persuasive personality, but able to balance and compromise different opinions.
- Strategic and solution-thinking skillsPrecise working style, persistence in pursuing objectives.
- Open-minded and good team working abilities.
- Fluency in written and spoken English, German and any other language an asset.

**Equal opportunities commitment**
dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there’s a place for everyone at dsm-firmenich.

dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.

We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.

**About dsm-firmenich**
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is es

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