Regulatory Affairs Specialist / Coordinator with Digital Focus

Fertin Pharma Group; Vejle; On-site; DKK 420,000 - 620,000; Full time

Job summary

Fertin Pharma Group in Denmark seeks a Regulatory Affairs Specialist/Coordinator with a digital focus to join the Regulatory Affairs team. The role blends regulatory responsibility with documentation and smart digital tooling to support product development and lifecycle management.

You will collaborate with Product Development, Business Development and other partners to translate regulatory requirements into practical guidance and compliant solutions.

Qualifications

• Relevant education within food science, science, regulatory affairs, quality or a related field.
• Experience from food, ingredient, nutraceutical, tobacco or pouch industry preferable within Regulatory Affairs.
• Experience with labelling, claims and international food legislation.
• Fluency in written and spoken English and Danish.
• Digital flair and interest in process improvement, digitalization and implementation of new systems.

Responsibilities

• Regulatory responsible during product development, life cycle management and in cross-functional projects.
• Perform regulatory legality assessment and product classifications.
• Advise on labelling, claims and market-specific regulatory requirements.
• Perform regulatory risk evaluations and provide balanced recommendations on risks, opportunities and possible mitigation measures, participate in relevant decision forums.
• Monitor regulatory legislation and requirements and communicate relevant developments.
• Perform regulatory documentation and ensure that information, workflows and systems are organized, accurate and compliant.
• Support continuous compliance and the timely completion of regulatory activities.
• Assist with process improvements, digitalization and automation initiatives.
• Contribute to knowledge sharing within the team and across functions.

Skills

Regulatory mindset

Communication

Analytical thinking

Collaboration

Documentation

Education

Food science / Regulatory affairs / Quality

Related field experience

Tools

Excel

Veeva RIM / Regulatory system

Job description

Job Details: Regulatory Affairs Specialist / Coordinator with Digital Focus

Full details of the job.

Job Title of Vacancy

Job Title of Vacancy Regulatory Affairs Specialist / Coordinator with Digital Focus

Vacancy No

Vacancy No VN2414

Category

Category Clinical, Medical and Regulatory Affairs

Contract Type

Contract Type Permanent

Contract Duration

Full Time / Part Time

Full Time / Part Time Full Time

Job Advert

Job Advert Are you a solution-oriented regulatory professional with an interest in both regulatory compliance and smarter digital ways of working?

We are looking for a full-time Regulatory Affairs Specialist or Regulatory Affairs Coordinator to join our Regulatory Affairs team.

Fertin’s Regulatory Affairs department consists of 19 employees organized into three teams. This position is within the team responsible for products in the categories of food, food supplements, nutraceuticals, pouches and other smoke-free products.

You will combine regulatory responsibility, risk management with documentation and digital support. Working closely with Product Development, Business Development and other internal partners, you will help translate regulatory requirements into clear, pragmatic guidance and compliant solutions.

Key responsibilities

• Regulatory responsible during product development, life cycle management and in cross-functional projects.
• Perform regulatory legality assessment and product classifications.
• Advise on labelling, claims and market-specific regulatory requirements.
• Perform regulatory risk evaluations and provide balanced recommendations on risks, opportunities and possible mitigation measures, participate in relevant decision forums.
• Monitor regulatory legislation and requirements and communicate relevant developments.
• Perform regulatory documentation and ensure that information, workflows and systems are organized, accurate and compliant.
• Support continuous compliance and the timely completion of regulatory activities.
• Assist with process improvements, digitalization and automation initiatives.
• Contribute to knowledge sharing within the team and across functions.

Your profile

You are a solution-oriented regulatory professional who combines technical expertise with business understanding. You have a structured and analytical mindset and can translate regulatory requirements into clear and practical guidance.

You communicate transparently and provide balanced recommendations that enable others to understand both regulatory risks and business opportunities.

You also:

• Thrive in a collaborative team environment and enjoy sharing knowledge.
• Work independently and take decisions within your area of responsibility.
• Have strong organizational and prioritization skills, with the ability to manage multiple tasks simultaneously and meet deadlines.
• Have strong collaboration and communication skills.
• Have a genuine interest in documentation and continuous compliance.
• Are a driver in digital tools and smarter ways of working.

Qualifications

• Relevant education within food science, science, regulatory affairs, quality or a related field.
• Experience from the food, ingredient, nutraceutical, tobacco or pouch industry preferable within Regulatory Affairs.
• Experience with labelling, claims and international food legislation.
• Fluency in written and spoken English and Danish.
• Digital flair and an interest in process improvement, digitalization and implementation of new systems.

Advanced Excel skills and experience with a Regulatory Information Management system, such as Veeva RIM or a similar system, will be considered an advantage.

We offer a varied regulatory position in a collaborative department where knowledge sharing, professional development and continuous improvement are important parts of how we work.

The position may be filled at either Specialist or Coordinator level, depending on your qualifications and experience.

The application deadline is 13 September. We expect to conduct first-round interviews during week 38, followed by second-round interviews in week 39. The successful candidate is expected to start on 1 November.