Regulatory Affairs Specialist

Regulatory Affairs Specialist - Medical Valley/Xiromed

Medical Valley/Xiromed is a fast-growing generic pharmaceutical company focused on tender markets across Europe. Our mission is to make healthcare more sustainable by offering affordable medicines, enabling healthcare systems to reallocate resources to newer and more advanced treatments.

Headquartered in Höllviken in Sweden, we operate across Europe and are part of INSUD Pharma, a global pharmaceutical group based in Spain with 9 500+ employees worldwide. We combine the entrepreneurial spirit of a growing organization with the stability and resources of an international pharmaceutical group.

We are now looking for a Regulatory Affairs Specialist to join our growing Regulatory Affairs team.

Curious to learn more about us? Read more on our website here.

About the Role

This is an exciting opportunity for someone who enjoys working in an international Regulatory Affairs environment where you will have genuine ownership of your own product portfolio.

You will manage regulatory submissions and lifecycle activities across several European markets, working closely with colleagues in Sweden, Spain and other countries. From new marketing authorisation applications to lifecycle management and regulatory compliance, you will play an important role in ensuring that our products reach patients efficiently and in accordance with European regulatory requirements.

Reporting to the Regulatory Affairs Manager, you will become part of an international team of twelve colleagues, with three team members based in Sweden. The role is based in Höllviken with a flexible hybrid working model.

This is a permanent position based in Höllviken, starting with a probationary period.

Key Responsibilities

• Manage regulatory submissions from preparation through approval
• Coordinate Marketing Authorisation Applications (MAAs) and lifecycle management activities
• Prepare and compile regulatory documentation, including responses to health authority questions
• Manage eCTD documentation and electronic submissions via CESP
• Coordinate national phase activities, including product information translations and artwork updates
• Ensure regulatory databases are maintained and regulatory commitments are fulfilled
• Support renewals, variations and ongoing portfolio management
• Monitor European regulatory requirements and assess their impact on the product portfolio
• Collaborate closely with Supply Chain, Quality, Artwork and external authorities across Europe
• Contribute to continuous improvement of regulatory processes and procedures

Who You Are

You enjoy taking ownership, working in a structured way and building strong relationships across functions and countries. You are proactive, solution-oriented and comfortable managing several activities simultaneously in a fast-paced environment.

You also bring:

• University degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Biochemistry or a related Life Science discipline
• At least 3 years of experience within Regulatory Affairs in the pharmaceutical industry
• Experience with European regulatory submissions and lifecycle management
• Good knowledge of EU pharmaceutical legislation, ICH guidelines and CTD/eCTD
• Experience with CMC documentation is an advantage
• Experience from generic pharmaceuticals or decentralized procedures is highly valued
• Fluent English, both written and spoken. Swedish is an advantage, while Spanish or another European language is considered a plus.

Why Join Us

You will join an international, entrepreneurial and growing company where your contribution truly matters. With short decision-making paths and a collaborative culture, you'll have the opportunity to influence both your own role and the future development of the Regulatory Affairs function.

As Medical Valley/Xiromed continues its ambitious growth across Europe, this position offers excellent opportunities to develop within Regulatory Affairs while broadening your experience across project management, portfolio management and international collaboration.

Application Process

In this recruitment, Medical Valley/Xiromed is collaborating with Agardh Recruitment & Consulting.

If you have any questions regarding the position or the recruitment process, please contact Pernilla Agardh at +46 (0)72 249 94 80.

Please submit your application as soon as possible. We review applications on an ongoing basis, so we encourage you to apply as soon as possible. We look forward to hearing from you.