Regulatory Affairs Manager

TN United Kingdom; Greater London; On-site; GBP 60,000 - 90,000; Full time

Job summary

An established industry player in biotechnology is seeking a Regulatory Affairs Manager to join their mission of improving lives through innovative solutions. This 12-month contract role offers a unique opportunity to work with a global team, advising on regulatory strategies and ensuring compliance with regional regulations. You will collaborate with various stakeholders and lead efforts to navigate complex regulatory landscapes, making a significant impact on product development. If you are passionate about regulatory affairs and want to contribute to meaningful advancements in healthcare, this role is for you.

Qualifications

• Experience in regulatory affairs within the biotechnology or pharmaceutical sector.
• Ability to navigate complex regulatory environments.

Responsibilities

• Advise the Global Regulatory Team on regional strategies.
• Manage regional leads and ensure compliance with local regulations.
• Act as a liaison with regulatory agencies.

Skills

Regulatory Affairs Expertise

Knowledge of Legislation

Communication Skills

Cultural Awareness

Education

Degree in Life Sciences

Certification in Regulatory Affairs

Job description

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: 10

Posted: 26.04.2025

Expiry Date: 10.06.2025

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:

1. Advising the Global Regulatory Team (GRT) on regional considerations in developing strategy.
2. Ensuring regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
3. Managing one or more regional leads or support roles.
4. Participating 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).
5. Acting as a contact with relevant regulatory agencies to fulfill local obligations by product assignment and documenting interactions.
6. Communicating details and outcomes of regulatory agency interactions to GRT and senior management.
7. Participating in core regulatory activities to ensure effective regional agency interactions, including contingency regulatory planning and risk assessment.

Knowledge and Skills - Regulatory Principles:

1. Working with policies, procedures, and SOPs.
2. Knowledge of relevant legislation and regulations related to medicinal products.
3. Understanding of regulatory procedures in the region for MAs, CTAs, post-approval changes, amendments, extensions, and renewals.
4. Cultural awareness and sensitivity to achieve results across regional and international borders.

If this role interests you, please apply now!