Freelance Associate Director

Freelance Associate Director - Global Regulatory Affairs
Regulatory Medical Writing - Labelling

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

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)

We try our best to respond to every application and you can be sure every single one will be reviewed.

Due to the potential high volume of responses should you not hear back within 10 days from your application assume you have not been successful on this occasion.

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

Recruitment Consultant - SEC Pharma 
(see below)