Regulatory Affairs Manager

Quanta part of QCS Staffing; Greater London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading biotechnology client seeks a Regulatory Affairs Manager for a 12-month contract in Greater London. This role entails advising on regulatory strategies and ensuring compliance with legislation, significantly contributing to the improvement of lives affected by disease through innovative medical solutions.

Qualifications

• Experience with regulatory policies, procedures, and SOPs is essential.
• Familiarity with MA, CTA regulations and post-approval processes is required.

Responsibilities

• Advise on strategy development and implement regional needs.
• Participate in core regulatory activities to ensure effective agency interactions.

Skills

Regulatory principles

Knowledge of medicinal products legislation

Drug development processes

Cultural awareness

Job description

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Regulatory Affairs Manager, Greater London

Client:

Quanta part of QCS Staffing

Location:

Greater London, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

7cc2b2d27c2e

Job Views:

23

Posted:

22.06.2025

Expiry Date:

06.08.2025

Job Description:

Regulatory Affairs Manager - Greater London - Life Science - 12-Month Contract

Our client, a globally recognised pioneer in Biotechnology, is recruiting for the position of Regulatory Affairs Manager. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to find solutions. This is your chance to join them on their global mission to improve the lives of those affected by disease and illness.

Responsibilities:

• Advising the GRT on regional considerations in developing strategy.
• Ensuring regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
• May manage one or more regional leads or support roles.
• 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, fulfilling local obligations by product assignment, and communicating details and outcomes of regulatory agency interactions to GRT and senior management.
• Participate in core regulatory activities under general supervision to ensure effective regional agency interactions, including contingency regulatory planning and risk assessment.

Knowledge and Skills - Regulatory Principles:

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

If this role interests you, please apply now!