Senior Regulatory Affairs Associate

Overview

Pharmaceuticals Regulatory Affairs Associate - Homebased and Office

This is a great opportunity for a Regulatory Affairs (RA) Specialist to develop your career in regulatory affairs for drug products. Do you have experience in product labelling activities and regulatory drug submissions? Do you have experience of Windsor Framework compliance? Have you compiled regulatory documents for submissions within the UK and Ireland? Looking for a contract role with an exciting global pharmaceutical company?

If yes then this is the role for you.

• Support regulatory strategies for assigned product portfolios and perform life cycle management submissions for medicinal drug products.
• Manage local Regulatory Affairs activities and help support business product launches and tender applications mainly for the UK and Irish markets.
• Support and maintain pharmaceutical product portfolios.
• Manage ongoing product information updates for Windsor Framework compliance.
• Support regulatory project plan execution.
• Assist in preparation and review of labelling and local SOPs.
• Maintain awareness of regulatory requirements relating to UKI regulations.
• Compile regulatory documents for submission.
• Maintain internal product information databases (e.g. RIM Vault) and change controls.

This is a 12 months contract role which will be reviewed for a possible extension or go permanent; this depends on the individual and business performance. The role is based on a hybrid pattern (home 3 days a week, office 2 days a week in Newbury, Berkshire) with the option to be on site every day. The client will also be flexible with 5 days a week working from home.

PAYE rate: £30.50.

• Bachelor's degree or equivalent in a relevant scientific discipline with experience of UK and Ireland drugs regulatory labelling requirements, Regulatory Authority submissions and Regulatory Authority communication/negotiation.
• Excellent project management skills.
• Computer skills (Word, Excel, PowerPoint, Outlook, corporate software).
• Good project management experience.

To apply for this opportunity, please send a Word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. Please ensure you have read and agree to our Privacy Policy which can be found on the Quality Start website.

If this sounds like the role for you or a colleague then please contact us. If we successfully fill a permanent placement from your referral, we will send you a cheque of £300. We also have incentive schemes for referring contractors/temp staff; please contact us for details. For a list of our current vacancies, please visit the Quality Start website. If you do not hear from Quality Start within 2 weeks, your CV has not been shortlisted for this role.

Quality Start are acting as a specialist recruitment consultancy for this role.