Associate Director

Associate Director - Global Regulatory Affairs
Regulatory Medical Writing - Labelling

Belgium
£ Excellent Rate/hour - Dependent on Experience
9 month initial contract + extensions

The successful candidate for this role will be responsible for the creation and maintenance of the Company Core Datasheets, US Package Inserts and EU Centralized Procedure/Mutual Recognition Summaries of Product Characteristics (SmPC) and Patient Labelling, as well as providing support for package labels for US and EU submissions.

Accountabilities/Responsibilities:

*Assisting the development of labelling strategy and backup strategies for label negotiation.
*Writing and revising Target Labels.
*Deriving and updating the Target USPI and SmPC from the Target Label.
*Preparing final USPI, SmPC, and CCDS for internal review before submission.
*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.

Essential Skills & Capabilities:

*A minimum of 5 years relevant experience in the pharmaceutical industry (eg Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc)
*Required understanding of the drug development process, regulatory submission and approval process and regulatory labelling requirements throughout the product life cycle.
*Knowledge of US and EU Regulations is required.
*A minimum of a Bachelor's Degree in the life sciences
*English spoken and written (Dutch is desirable)

If this position might be of your interest, please forward your CV to my email address (see below)
If you are interested in different role, please still send your CV stating what would you look for.

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

Diana Fryzowicz
Associate Consultant - SEC Pharma  
(see below)