Regulatory affairs associate Middle East

Job description

Who we are ?

Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care. 

Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan. 

In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.

Pierre Fabre is recognized as one of the "World's Best Employers 2021" by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide. 

Your mission

·  Submits registration/notification files for Pierre Fabre products to the appropriate local Authorities
·  Ensures maintenance of marketing authorisations/notifications (e.g., renewals, variations, payment of fees as relevant, …)
·  Prepares and validates packaging information in accordance with the country’s legislation in force
·  Validates promotional documents in accordance with the country’s legislation in force
·  Organises the archiving and traceability of local files and documents.
·  Assists in any regulatory activity needed to ensure the reimbursement, customs clearance, and the commercialisation according to local legislation (e.g., registration of manufacturing sites,)
·  Manage and improve the exsiting Quality Management System according GxP’s and Corporate requirements for all activities dealing with OTC drugs, prescription Drugs, Medical Devices, Cosmetics, biocides and Food supplements
·  Managing annual budget for the regulatory activities

Who you are ?

·  You have a Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
·  A master’s degree or PharmD are a plus.
·  Minimum of 3 years ’ experience in regulatory affairs within the pharmaceutical company in UAE
·  Strong understanding of pharmaceutical regulations and guidelines
·  Familiarity with global regulatory frameworks and compliance standards.
·  Proven track record of successful regulatory submissions and approvals.
·  Proficient in preparing and reviewing regulatory documentation
·  Knowledge of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards.
·  Strong analytical and problem-solving abilities to assess regulatory requirements and compliance.
·  High level of accuracy and attention to detail in documentation and reporting.
·  Excellent written and verbal communication skills to effectively interact with regulatory agencies and cross-functional teams.
·  Strong organizational skills with the ability to manage multiple projects and deadlines efficiently.
·  Ability to work collaboratively across departments to ensure compliance and support product development.
·  Capacity to stay current with changes in regulations and industry standards.
·  Position based in United Arab Emirates

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.