Regulatory Affairs Manager - Uxbridge, United Kingdom - PE Global

Description

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.