Director of Policy and Regulatory Affairs

1 month ago

London, United Kingdom ACHIEVA Group Limited Full time

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.
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.

Advising the Global Regulatory Team on regional considerations in developing strategy
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. 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.

Working with policies, procedures and SOPs.
Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.

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