Global Regulatory Affairs Manager, Technical Dossier Compliance Apply Now

Job Family

Regulatory

City

La Tour-de-Peilz

Region

Vaud

Country

Switzerland

Contract Type

 

Posting Start Date

08-Dec-2020

Company Overview

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 of prescription medicines, aesthetics solutions and consumer care products. 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 solutions for the skin. For more information, please visit www.galderma.com    

Job Description

We are currently looking for the Global RA Manger Technical Dossier Compliance to join our growing global RA team. The role is based in Entre-deux-Villes, Switzerland and will report to the Global RA Senior Manger Technical Dossier Compliance and Systems.

The core mission:

Under the supervision of the Team Head, the RA Manager contributes to the global preparation of technical parts of the master cosmetic dossiers for worldwide registration.

Job Responsibilities

• Focal point of contact for sites, procurement & supply, quality and formulation teams.


• In charge of the preparation of the technical master cosmetic dossiers: for products in development and life cycle maintenance (Change Control, annual update... ).


• Performs the gap and impact analyses of changes.


• Ensures compliance with relevant worldwide regulations from a technical standpoint.


• Gives Strategic technical regulatory input for Cosmetic worldwide dossier preparation.


• Monitor International regulations.


• Set-up processes and adaptation of pre-existing toots for cosmetics in collaboration with previously specified worldwide stakeholders.

Minimum Requirements

Work Experience:

• Minimum 3 years of prior experience in global Regulatory Affairs in the Consumer Care environment (Cosmetics/Medical devices).


• CMC technical expertise.

 

Required Skills and Knowledge:

• PhD (in Sciences, Medicine or Pharmacy), Master or any equivalent advanced scientific degree in a related technical field.


• Strong knowledge of the pharmaceutical & cosmetic industry, including solid knowledge of all associated global RA regulations.


• Strong organizational skills.


• Excellent team interaction skills along with demonstrated ability to work on a cross-functional team.

 

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