Regulatory Affairs Manager

AGB-Pharma is growing, and we are looking for a Regulatory Affairs Manager who wants new challenges and to be part of a dynamic regulatory team. At AGB-Pharma, a Swedish, family-owned, pharmaceutical company, we are committed to improving the lives of patients suffering from sleep disorders.

The position

As our new Regulatory Affairs Manager, you will be part of the highly skilled and dedicated Regulatory Affairs, Quality Assurance & Pharmacovigilance team of seven colleagues at our head office in Lund. You will play a key role in both the development and commercialisation of new products, as well as the lifecycle management of products already on the market. The role covers regulatory activities across various markets in Europe and the rest of the world.

You will provide strategic regulatory advice to the organisation and lead and contribute to critical regulatory activities. As a member of the team, you will have the opportunity to shape the way we work and to contribute to the development of our processes.

Key responsibilities

· Prepare and submit regulatory documentation for approval of new and existing products, especially assessing and creating CMC documentation.

· Respond to questions from regulatory authorities.

· Assess the regulatory impact of CMC changes.

· Monitor and interpret regulatory intelligence and ensure up-to-date knowledge of relevant legislation and compliance with applicable regulations and guidelines.

· Provide regulatory expertise in cross-functional project teams.

· Actively contribute to the development and optimisation of internal processes and ways of working.

Who you are

We are looking for a candidate with a proactive mindset and a collaborative spirit. You are structured, solution-oriented, and thrive in a dynamic environment.

Qualifications

· Minimum 5 years professional experience in Regulatory Affairs within the pharmaceutical industry or from a Health Authority.

· Strong knowledge of CMC, with experience of compiling and reviewing documents and reports in accordance with global regulatory regulations and guidelines.

· Project management skills and excellent communication and documentation skills.

· Master’s degree in Life Sciences, Pharmacy or related field.

· Fluency in in both written and spoken Swedish and English.

What we offer

At AGB-Pharma, you’ll be part of a small, agile organisation where every individual makes a real impact. We offer:

· A dynamic and entrepreneurial work environment.

· A supportive, positive and can-do attitude.

· Opportunities for both personal and professional development.

· The chance to contribute to products that make a meaningful difference in patients’ lives.

Apply Now

If you’re passionate about Regulatory Affairs and want to be part of a team where your expertise is truly valued, please submit your application with CV and cover letter to recruitment@agb-pharma.com no later than 30th of September. Selection is ongoing – don’t wait to submit your application.

We look forward to hearing from you!