GALDERMA is one of the Pharmaceutical leaders in Dermatology. GALDERMA provides dermatology solutions and
aesthetic and corrective products internationally. The company has 33 wholly-owned affiliates and a worldwide network
of distributors, 5 000 employees and an extensive product portfolio available in 80 countries. We are seeking for our
R&D Centers in France (Sophia Antipolis) or Sweden (Uppsala):
Within the Scientific Division Global Regulatory Affairs Department and Global Regulatory Operations (GRO)
Group, you will be in charge of the production of regulatory documents for international filings (US, EU, CAN,
JPN,) for Prescription products, Medical Devices or Biologics and support to clinical programs. Your main
- As member of the Global Project teams, represent as Global Regulatory Operations Project Team Representative
the expertise of GRO and more specifically scientific writing, and to apply project management methods to document
- To propose document production strategies and select and recommend external writing partners (outside
contractors) to management, as needed.
- For Prescription products, Medical Devices or Biologics, to produce multidisciplinary documents covering Clinical,
Quality and Non Clinical information such as Investigators Brochures, Briefing Packages, Pediatric plans (PSP and PIP),
IND/IDE, IMPD, NDA/PMA/BLA, Responses to authorities but also Clinical Study Reports (Phases 1 to 3), according to
Projects defined timelines and Galderma quality standard:
- Ensure early and consistent message and format definition, careful planning, and overall management of
the document production process, in collaboration with other internal and external experts when
- Collect, analyze, interpret and synthesize all relevant
- Write up and/or coordinate internal or external
- Ensure that key messages and critical issues are
accurately and consistently addressed across documents.
- Manage review, approval and release of each document, through proper liaison with peers and other
experts in various R&D departments and Galderma sites.
- To contribute to GRO insurance and update SOPs, to interface process fine-tuning with other departments, to
participate in the global standardization of processes (e.g. through involvement in task-forces or dedicated working
Candidate profile :
You have a Bachelor of Science, Master, Pharmacy, Doctoral or equivalent. You have more than seven years of work
experience within industry R&D (Pharmaceutical, Cosmetics, Medical Device and/or Biologics) among which at least
five years in similar position. Fluent English with strong written skills.
Position based in one of the Galderma R&D centers in Europe in France (Sophia Antipolis) or Sweden (Uppsala).
Open position, salary to be defined regarding experience & profile.
If you are interested in this position, we thank you to send your application,
referenced SA/SW0515/GRD by email to: firstname.lastname@example.org
GALDERMA, DRH - Les Templiers - 2400, route des Colles - Sophia Antipolis, 06410 Biot