Global Regulatory Affairs Manager OTC Apply Now

Job Family

Business & Corporate Development

City

La Tour-de-Peilz

Region

Vaud

Country

Switzerland

Contract Type

 

Posting Start Date

17-Nov-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 a Global RA Manager OTC to join our growing global RA team. The role is based in Entre-deux-Villes, Switzerland and will report to the Global RA Head OTC.

Global Regulatory Affairs Manager OTC

(18 months employment contract)

The core mission:

Under the supervision of the Team Head, the RA Manager contributes to the development, preparation of dossiers and global coordination of OTC drugs for regulatory aspects for worldwide registration. The role also includes knowledge on Medical Devices.

Job Responsibilities

• Setting up the regulatory strategy for projects under development


• Cooperates with affiliates (through hubs) in order to perform a feasibility analysis of projects roll out WW based on regional/national regulations


• Coordinates the preparation and participates to meetings with Health Authorities/Notified Bodies if necessary


• Communication of project relevant RA information to Project Team and Department Heads


• Represents RA in global & cross functional meetings


• Provides regulatory support to ensure the content of dossier/technical files is compliant with relevant regulations and is sufficient for submission


• Updates Product Information periodically or upon specific request


• Ensures regulatory support for new product launch


• Maintains and tracks RA activities databases


• Supports the development of labelling and artworks

Minimum Requirements

Work Experience:

• Several years (>5) of prior experience in global Regulatory Affairs in the Consumer Care environment (OTC drugs and Medical Devices).


• Strong interpersonal, communication and organizational skills.

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 OTC drugs and Medical Devices industry, including solid knowledge of all associated global RA regulations.


• Experience in classification change / OTC switch desired.


• Experience in combination product desired.

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