Regulatory Affairs Manager, Lifecycle Management for Galderma

About Galderma

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. For more information, please visit www.galderma.com.



Om Galderma

Galderma, världens största oberoende globala dermatologiska företag, grundades 1981 och finns i 100 länder med en omfattande produktportfölj för behandling av olika hudåkommor. Företaget samarbetar med vårdpersonal världen över för att tillgodose människors dermatologiska behov under livets olika faser. Galderma är ledande inom forskning och utveckling av vetenskapligt definierade och medicinskt dokumenterade lösningar för huden och dess åkommor. Mer information finns på www.galderma.com/se

Job description / Arbetsbeskrivning

Do you have experience of working with regulatory affairs? Are you used to working on several different markets at the same time and interested in joining a growing global company with an amazing culture and interesting opportunities? If so, you should keep reading since we are now looking for a Regulatory Affairs Manager to our Uppsala site.

As Regulatory Affairs (RA) manager within Lifecycle Management (LCM) at Galderma in Uppsala, you will be part of a team of ten RA professionals that work with covering all LCM aspects of RA for the portfolio of products at Galderma. You will be responsible for the development of strategies for LCM activities, to assess and ensure implementation of regulatory requirements across many different markets and authorities, and to assess regulatory impact of labeling updates. You are also expected to provide regulatory guidance in general within the Galderma organization.

Job responsibilities / Ditt uppdrag

You will lead the strategic work for regulatory LCM activities in projects and for specific line activities in close collaboration with Global strategic Marketing, Supply Chain, affiliates and other relevant functions. Specifically, you will take lead in key Regulatory/cross functional project(s). Day to day activities may include:

* Strategic planning and project management of key LCM project(s)
* Providing regulatory expert advice in project and line related activities
* Compiling overall regulatory strategy within LCM projects and line extensions
* Regulatory strategy in connection to labeling and other changes
* Filing and obtaining marketing applications worldwide
* License maintenance activities
* Coordinating compilation of new and updated labeling material
* Compiling, reviewing and approving documentation for regulatory purposes
* Contacting regulatory bodies, affiliates, partners, consultants and distributors
* Tracking of regulatory status and plans within respective product responsibility

Minimum requirements/ Är du den vi söker?

To be successful in this role you have experience from the field of Regulatory Affairs within Medical Device or the Pharmaceutical industry. Furthermore, you:

* have a university degree within the Pharmaceutical area or similar
* are fluent in Swedish and English, both orally and in writing
* likely have previous experience from project management

You are used to, and enjoy, communication and collaboration both internally and externally with colleagues, authorities and affiliates. You have an engaged, flexible and focused way of working, with the ability to see both the whole picture and the details.

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

Galderma is the world's largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we're in shapes our life stories, we are advancing dermatology for every skin story. For more information, please visit our website: https://www.galderma.com/careers

Other important information/ Frågor och ansökan

Please apply with CV and cover letter via this page, alternatively via the link Apply now, no later than November 14th. Selection and interviews might be done continuously so do not wait with your application.

If you want to know more about the role you are welcome to contact Talent Acquisition Manager, Marlene Andersson at marlene.andersson@galderma.com