Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically defined and medically proven innovative solutions for the skin.

With innovation as a driving force, Galderma provides a wide range of medical solutions which meet the highest standards of safety and efficacy. Several major brands in its growing portfolio treat acne, rosacea, psoriasis and other steroid responsive dermatoses (SRD), onychomycosis (fungal nail infections), pigmentary disorders, skin cancer and include medical solutions for skin senescence. In 2011, Galderma acquired Q-Med, a Swedish medical device company specialized in aesthetics, strengthening Galderma’s presence in the aesthetic market.

Headquartered in Lausanne, Switzerland, Galderma has more than 5,000 employees and 35 affiliates around the world. Its products are distributed in over 100 countries.

The site in Uppsala hosts our Nordic affiliate Galderma Nordic AB and the global unit for Aesthetics (Q-Med AB). Over 430 employees work with the development, manufacturing and marketing of Galderma´s aesthetics products.

Galderma manufactures and/or distributes many well-respected brands, including Epiduo™ Restylane® Oracea® Differin® Mirvaso® Soolantra® Loceryl® Benzac® Excipial® Metvix® Azzalure® Sculptra® Tri-Luma™ Cetaphil® and Daylong™

For more information, please visit http://www.galderma.com

 

Senior Regulatory Affairs Manager

Sr Regulatory Affairs Manager
The Sr RAM belongs to the Regulatory Affairs Department at the office in Uppsala.
The work as Sr RAM covers all aspects of Regulatory Affairs for the company portfolio of products. The position is responsible for the development of strategies for new product applications, for worldwide regulatory submissions, to assess and ensure implementation of regulatory requirements, to assess regulatory impact of labeling updates and where necessary notify authorities and to provide regulatory guidance in general to projects and organization.
The role will also provide coaching and mentoring to team members, to increase regulatory affairs awareness in the company.

We are looking for an organized, highly motivated and goal-oriented person with long experience from Regulatory Affairs within the Life Science area. It is important to be able to work independently and take own decisions to be able to accomplish projects and deliver results. It is also important to be able to work in teams together with colleagues. The person needs to be structured with the ability to prioritize and make things happen. To be flexible and have a positive open mind attitude is important. Furthermore, our candidate needs to be a good communicator.

Accountabilities
• Provide regulatory expert advice in project and line related activities
• Compile overall regulatory strategy within projects for new products and line extensions including variations
• File and obtain marketing applications worldwide
• License maintenance activities
• Filing of clinical trial applications to authorities
• Coordinate compilation of new and updated labeling material
• Compile, review and approve documentation for regulatory purposes
• Remain updated on current regulatory requirements
• Lead, coordinate contact with regulatory bodies, affiliates, partners, consultants and distributors including meeting participation
• Tracking of regulatory status and plans within respective product responsibility
• Represent RA both internally and externally
• Prepare and participate in company audits both internal and external
• Represent RA in Due diligence of new business opportunities

Required profile
We are looking for an experienced Regulatory Affairs Manager within Life Science, with excellent skills in communication and collaboration, and attracted to work for a growing and healthy company with massive investment in Uppsala.

Qualifications
• Degree at University level within the Pharmaceutical or similar areas
• Several years of experience from the field of Global Regulatory Affairs in the Medical Device or Pharmaceutical industry is essential
• Experience of regulatory requirements in the development and manufacture of medical devices is advantageous
• Fluently in Swedish and English, orally and written language

Contact
For further information about the position, please contact Jarl Molin or Marta Frick Senior Recruitment consultants at PeakSearch. Apply for the position at http://www.peaksearch.se

Jarl Molin; jarl.molin@peaksearch.se
Mobil: +46 70 560 20 56

Mara Frick; marta.frick@peaksearch.se
Mobil: +46 70 386 89 69