Regulatory Affairs Manager

Sinéad Breen, Head of Regulatory Affairs: 076 898 12 30

Please go to www.q-med.se to apply for this position as soon as possible though no later than August 26, 2013. Due to the holiday season, response to phone calls and e-mails might be delayed. We will do our best to respond. Welcome with your application!


At Galderma, more than 4 000 people are committed to delivering innovative medical solutions, to meet the dermatological needs of people throughout their lifetime. Just as the skin is a unique system within our body, we offer a unique and complete portfolio to care for the skin: from prescription and self-medication drugs to aesthetic & corrective solutions.

Located in Uppsala (Sweden), Q-Med AB is the global center of excellence for Aesthetic & Corrective, with state-of-the-art research, development and manufacturing. Here our 400 employees are committed to aesthetics and leading brands such as Emervel®, Restylane® fillers, Skinboosters and Skincare. For more information, please visit www.galderma.com or www.q-med.com

Our global regulatory affairs (RA) department manages new product registrations, line extensions, life cycle, change control submissions and CMC writing for Galderma aesthetic & corrective business.

We are now looking for a Regulatory Affairs Manager, to lead the strategic work for regulatory activities in our development projects and for specific line activities, in close collaboration with other departments. This is a permanent position based in Uppsala, reporting to a Group Manager RA.

As a RA Manager you will have a leading role to manage projects in development as well as support our country organizations with all aspects of our worldwide regulatory submissions. Your responsibilities will include:
• Develop regulatory strategies and identify relevant documentation requirements for submissions worldwide.
• Compile regulatory submission documents for defined markets in accordance with current country specific requirermnts.
• Compile documentation for clinical trial applications in accordance with country specific requirements.
• Act as regulatory contact person for regulatory authorities.
• Participate and contribute to scientific advice meetings.
• Create, review and approve reports and other relevant documentation from a regulatory perspective.
• Remain updated on current regulatory requirements
• Compile texts for label (package inserts, prescribing information etc.)