Regulatory Affairs Associate

4 days left

Employer
Location
Slough
Salary
Market related
Posted
Sep 05, 2016
Closes
Oct 03, 2016
Ref
RA.NW.9024
Contact
Nicholas Walker
Result Type
Jobs
Position Type
Permanent
Hours
Full Time

Our client, a leading global healthcare company, requires a Regulatory Affairs Associate to join their team based in Slough, UK.

We require candidates with demonstrable OTC experience or commercially astute individuals to join the team, who can classify themselves as 'innovators and thinkers' who possess a pro-active, diligent approach to their work and thrive in robust, fast-paced environments.

Responsibilities:

  • Regulatory compliance for UK Marketing Authorizations in RB's portfolio, including preparation and submission of variation packages and renewals to the Regulatory Agency
  • New submissions/eCTD/NeeS
  • Extensive CMC experience for UK submission of type I and type II variations (including grouping and work-sharing), such as site transfers, change of manufacturing processes, FSP and analytical methods
  • Gap analysis of quality dossiers for licensing, including experience in reviewing and quality check of CMC documents for electronic submission to MHRA
  • Submission of type II safety variations to update SmPC and labelling in line with Company Core Data Sheets
  • Working with PV on PSUR submissions and SmPC updates
  • Creation and assessment of internal quality and non-quality changes in line with the change control management system
  • Artwork review and approvals (PIL, primary and secondary packaging), including preparation of User Test Bridging Reports for the approval of leaflet changes.
  • Work collaboratively with the relevant country teams to establish and implement the regulatory strategies within agreed timescales to bring competitive advantage to RB brands.
  • Support UK Drug Safety Officer and relevant qualified employees to ensure compliance with pharmacovigilance and quality obligations.
  • Interpret and apply all relevant legislation in the UK to keep the RB business up to date on national regulatory trends, risks and opportunities
  • Provide regulatory support and advice to other functions to ensure products are maintained in compliance with the local requirements.

If this role is of interest, please forward your CV to Nicholas Walker - n.walker@proclinical.com - or call +44 (0)207 4400 678 for more information. 

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