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