Regulatory Affairs Manager

Job type:
on-site
Start:
ASAP
Duration:
4 months
From:
Hays Resource Management - Astrazeneca
Place:
Bedfordshire
Date:
04/11/2013
Country:
flag_no United Kingdom

Project description:
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This project is archived and not active any more.
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The role:

The Regulatory Affairs Manager will be responsible for:

  • Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
  • Develop professional working relationships with assessors and administrative staff within the regulatory agencies
  • Prepare high quality regulatory applications and regulatory responses for UK/Ireland/Malta Defend existing labelling and provide regulatory input into patent defence strategies
  • Ensure timely submission of all licence variations and renewals and compliance with UK/Ireland/Malta licences
  • Ensure clinical trial applications are filed to target, and amended to remain in compliance
  • Assure appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs
  • Provide regulatory input/solutions to stock issues
  • Liaise with Operations to manage pack changes and ensure labelling compliance
  • Deliver the brand/commercial objectives, including representing Regulatory Affairs on Brand Lifecycle/Campaign Development/Customer shaping teams as appropriate
  • Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence
  • Take a lead role in project management and delivery
  • Understand and promote UK/Irish business needs into European strategies on drug development and regulatory filings/issues
  • Ensure appropriate cross functional input into the delivery of optimal licence strategies
  • Keep up-to-date with developments in the Regulatory Environment and share this knowledge across the department and beyond, in the business interest
  • Ensure departmental processes and organisation are continuously reviewed for creativity, efficiency and productivity (including leading one-off major projects
  • Actively contribute to cross-functional team working within the Medical & Regulatory Directorate and other areas of the business
  • Responsible for planning and executing workload for the defined product responsibilities and agreeing plan with Regulatory Team Manager

Qualification

  • Life Sciences Degree or equivalent
  • Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
  • Experience of working with submissions in UK and Europe
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