Manager, Regulatory Affairs Pharma

Manager Regulatory Affairs Pharma

Are you ready for the next challenge? As Manager Regulatory Affairs – Pharma within the Health, Nutrition & Care (HNC) business unit of dsm-firmenich, you will be part of a cross-functional team of around 15 employees, 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.

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.

We bring:

• A rich history and a promising future of bold scientific innovation and passionate creation with our customers.
• A space to grow by encouraging and supporting curiosity and an open mindset.
• An eagerness to be one team and learn from each other to bring progress to life and create a better future.
• A firm belief that working together with our customers is the key to achieving great things.
• A culture that prioritizes safety and well-being, both physically and mentally;

You bring:

• University degree in chemistry or natural sciences life sciences, or equivalent
• At least 3 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

About dsm-firmenich

At dsm-firmenich, we don’t just meet expectations – we go beyond them.

Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.

From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions – every single day. Whether it’s fragrance that helps you focus, alternative meat that’s better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.

And while you’re making a difference, we’ll make sure you’re growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They’re essential to our future.

Because real progress only happens when we go beyond, together.

DEI and equal opportunity statement

At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work – and that’s exactly the kind of culture we’re building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.

We’re proud to be an equal opportunity employer, and we’re serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we’re committed to reflecting the world we serve.

We welcome candidates from all backgrounds — no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.

And if you have a disability or need any support through the application process, we’re here to help – just let us know what you need, and we’ll do everything we can to make it work.

Agency statement

We’re managing this search directly at dsm-firmenich. If you’re applying as an individual, we’d love to hear from you. We’re not accepting agency submissions or proposals involving fees or commissions for this role.

Read Full Description