Job Description
PE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract.
Responsibilities of the role:
* Advising the GRT 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.
* Under general supervision participates in core regulatory activities to ensure effective regional agency interactions.
* Review and approve materials for use in the EU.
* Strategy and Execution Plans and manage regulatory submissions.
* Implement product related regulatory strategies, Regulatory Affairs processes and activity planning.
* Manage in the development of the regional product label with the Labelling Working Group.
* Supports regional label negotiation activities, participate in the development and execution of regional regulatory product strategies.
Requirements:
* 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.
Interested candidates should submit an updated CV.
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