REGULATORY AFFAIRS PROJECT LEADER

REGULATORY AFFAIRS PROJECT LEADER

...A transversal role that is involved in the market launch of all our products

Assignment

Analyze, propose and assess regulatory strategies related to the development, registration and variations of the products entrusted

Main activities

  • Coordinating preparation of regulatory dossiers
  • Implementing a technological watch
  • Interfacing with competent authorities
  • Providing support to subsidiaries
  • Managing promotional components and validating packaging items.

Profile

  • Formation :Training: Pharmacist + complementary training in health law
  • Significant initial experience in regulatory affairs (parent company or subsidiary)
  • Knowledge of regulations in effect
  • Fluent English
  • Analytical ability, ability to summarize, rigor and anticipation

Regulatory affairs project leader at Pierre Fabre Laboratories:

Regulatory affairs project leaders work on a defined product portfolio (pharmaceuticals, cosmetics, medical devices or food supplements). The teams to which they are assigned are organized by therapeutic areas, product ranges or geographical zones.