Manager Global Regulatory Affairs

Job description

Regulatory Affairs Manager – International & Emerging Markets

Blackfield Associates is proud to be partnered exclusively with an international pharmaceutical organisation that is expanding its International & Emerging Markets Regulatory team. We are seeking an experienced Regulatory Affairs Manager to take ownership of regulatory activities across EMEA and emerging markets.

This is a hands‑on role for a regulatory professional with proven experience taking approved dossiers and managing local submissions across emerging markets, including direct interaction with Health Authorities.

Key Responsibilities:

• Prepare and submit new Marketing Authorisation Applications (MAAs) supporting international countries within the Emerging markets region
• Support global expansion through the submission of registration dossiers for existing products
• Lead dossier remediation activities, including aligning legacy registrations with current regulatory requirements to enable geographic expansion
• Support lifecycle management of marketed products, including Variations, Renewals, and PSURs
• Liaise closely with local Regulatory Affairs affiliates on regulatory documentation, including labelling, variations, and new registrations
• Provide hands‑on support for country‑specific labelling requirements
• Track registrations using relevant regulatory databases and tracking systems
• Provide regulatory input to cross‑functional teams, including portfolio management, out‑licensing, and launch management
• Proactively contribute to the development and continuous improvement of the Regulatory Affairs function, supporting the successful commercialisation of products across international markets within EMEA

Required Experience & Qualifications

• Degree‑qualified in a Life Sciences discipline or related field
• Minimum 5 years’ experience supporting international regulatory markets
• Proven experience managing new MAAs, global expansion of existing products, and extensive lifecycle maintenance (essential)
• Experience working closely with international Regulatory Affairs affiliates
• Strong ability to manage multiple priorities and deadlines simultaneously
• Able to work independently while contributing effectively within a collaborative team environment

Additional Information

• This is a permanent, full‑time position
• Based at the Slough affiliate office, with hybrid working required
• Sponsorship is not available – candidates must have full right to work in the UK
• Flexibility around working hours is required due to international territories

Extra information

Status

Open

Education Level

Secondary School

Location

Slough

Type of Contract

Full-time jobs

Published at

19-05-2026

Profession type

Retail

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English