Global Regulatory Affairs Manager – Biopharma

JR United Kingdom; Hemel Hempstead; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading global pharmaceutical company is seeking a Global Regulatory Affairs Manager in Hemel Hempstead. The role involves managing regulatory strategies for a recently licensed product, ensuring compliance across EU and international markets. Candidates should have a life science degree and significant experience in regulatory affairs, particularly in the context of rare diseases.

Qualifications

• Minimum of 5 years of Regulatory Affairs experience.
• Experience in registering new drug products in ROW countries.
• Experience with centralized procedure in the EU is advantageous.

Responsibilities

• Lead the design and execution of regulatory submissions.
• Manage post-approval submissions in approved territories.
• Support clinical trial applications and orphan designation requests.

Skills

Regulatory Affairs

Knowledge of EU markets

Knowledge of international markets

Education

Life science-related degree

Job description

Global Regulatory Affairs Manager – Biopharma, Hemel Hempstead

Client: [Client Name]

Location: Hemel Hempstead, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views:

1

Posted:

23.05.2025

Expiry Date:

07.07.2025

Job Description:

Apsida is recruiting on behalf of a well-established, global pharmaceutical company expanding its rare disease portfolio. We are seeking a Global Regulatory Affairs Manager to manage and implement EU/US/ROW regulatory strategies for a recently licensed product.

This organization has a strong portfolio across multiple therapeutic areas, including rare diseases.

Responsibilities:

1. Lead the design and execution of regulatory submissions such as variations, renewals, and CTA applications.
2. Manage post-approval submissions in approved territories (EU/US) and oversee submission processes in ROW countries with CROs/partners.
3. Handle submissions for new and ongoing marketing authorization applications globally.
4. Support clinical trial applications, scientific advice procedures, orphan designation requests, and Paediatric Investigation Plans (PIPs) for new indications in development.

Requirements:

1. Life science-related degree.
2. Minimum of 5 years of Regulatory Affairs experience, with knowledge of EU and/or international markets.
3. Experience in registering new drug products in ROW countries.
4. Experience with the centralized procedure in the EU is advantageous.

If interested, please contact Ethan Cortese at Apsida Life Science. Apsida is a specialist recruitment firm based in London, Redhill, and Boston, dedicated to delivering top talent to the life sciences industry. We focus on providing high-quality, cost-effective, and trusted recruitment services that prioritize the candidate experience.