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Regulatory Affairs Manager

Website Achieva Group Limited

++ Regulatory Affairs Manager – 12 month contract (inside IR35) ++

Within this role you will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team, you will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.

The purpose of the role:

  • Ensure that the client acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
  • Ensure timely regulatory compliance with above approvals.
  • This role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff.

 
Responsible for:

  • Advising the Global Regulatory Team on regional considerations in developing strategy
  • Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
  • May manage one or more regional leads or support roles
  • May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. IMT, IBT, NAMT)
  • Act as a contact with relevant regulatory agencies in fulfilling local obligations.
  • Participate in core regulatory activities to ensure effective regional agency interactions are consistent with the Global Regulatory strategy.
  • Region Specific Activities, EU: Review and approve promotional and non-promotional materials for use in the region EM: Manage the product lifecycle for individual countries per national agency requirements EM: Work through the regional leads to manage distributor markets.
  • Strategy and Execution Plans and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within the client’s portfolio.
  • Supports regional label negotiation activities and participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.

 
Knowledge and Experience Required:

  • Working with policies, procedures and SOPs.
  • Knowledge of relevant legislation and regulations relating to medicinal products.
  • Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
  • Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and international borders.

 
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk

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