Associate Director - Global Regulatory Affairs - Labelling

Associate Director - Global Regulatory Affairs - Labelling
Prestigious Pharma Company
Based in Belgium
£ Excellent Rate/hour - Dependant on Experience
Possible extension based on performance
4 days a week, on site

For a confidential consultation call Audrey Petitier or email your CV to (see below)

Job Summary:

Opportunity for an experienced pharmaceutical professional to join one of the world's top 10 pharmaceutical companies as an Associate Director in their Global Regulatory Affairs Department. The role sits within the regulatory medical writing unit and will see you operating at a senior level, working cross functionally and providing strategy to all labelling matters.

Accountabilities/Responsibilities:

In this role you'll be focusing on:
-The creation and maintenance of the Company Core Datasheets (CCDS), US Packages Inserts (USPI), Centralized Procedure or MRP EU Summaries of Product Characteristics, EU Summaries of Product Characteristics (EUSPC) and Patient Labelling
-Managing the development of the label and the labelling process throughout the life of the product beginning with the Target Label (TL) in early development
-The creation and maintenance of the Company Core Datasheets, US Package Inserts and EU Centralized Procedure/Mutual Recognition Summaries of Product Characteristics (SmPC)
-Contribution to development of labelling strategy and backup strategies for label negotiation
-Writing and revising Target Labels during development that are aligned to clinical, commercial and regulatory strategies and in response to evolving data
-Maintaining the CCDS, USPI and SmPC in the post-approval environment. Interfacing with the Labelling Operations function to ensure that changes are being tracked and advise on local label audits
- Providing labelling support necessary to defend the company labelling position when issues arise

Essential Skills & Capabilities:
Educated to a minimum of Bachelor's degree in the life science, you will have:

- 5 years' experience in the pharmaceutical industry
-An understanding of the drug development process, regulatory submission, approval processes, regulatory labelling requirements as well as how labelling interfaces with the manufacturing and commercialization processes.
-Knowledge of the US and UK regulations

Medical writing, editing skills (for XML-based electronic environment) are a plus for this opportunity.
-Be fluent in English
-Dutch language is highly desirable

For further details or a confidential conversation please contact me directly:

Andrey Petitier
Contract Division - SEC
(see below)