Senior Manager Global Regulatory Affairs

Blackfield Associates
Slough
6 days ago
Applications closed

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Blackfield Associates are proudly partnered with an international pharmaceutical client on an exclusive basis, who are looking to establish a new team for their international and emerging markets division. We’re looking for an experienced Regulatory Manager to execute activities across international markets and EMEA. This includes submission and maintenance of new products, both generic and speciality, as well as supporting the global expansion of existing products.


As Regulatory Affairs Manager, you will:

  • Preparation and submission of new marketing authorisation applications, supporting international countries within the EMEA region
  • Preparation and submission of registrations for existing products as part of global expansion activities
  • Lead dossier remediation activities, such as aligning older registrations with current regulatory requirements in support of geographic expansion.
  • Support lifecycle management activities for marketed products, including Variations, Renewals and PSURs
  • Liaise with local Regulatory Affairs staff on regulatory documentation, including labelling, variations, and new registrations.
  • Support local Regulatory Affairs teams with countries-specific labelling activities.
  • Track registrations using relevant regulatory databases and tracking systems.
  • Maintain regulatory archives, including dossiers, documents, and media.
  • Provide regulatory support to cross‑functional teams (portfolio management, out‑licensing, launch management)
  • Proactively contributes to the strategic development of the Regulatory Affairs function and supports the successful commercial development of international markets within the EMEA region.


To be considered for the role of Regulatory Affairs Manager, you will have:

  • Educated to degree level in relevant life sciences studies.
  • Minimum 5 years’ experience supporting international markets.
  • Previous experience managing New MAA’s, Global expansion of existing products and extensive lifecycle maintenance is essential.
  • Experience working closely with international Regulatory Affairs affiliates.
  • Strong ability to manage deadlines and priorities multiple projects simultaneously.
  • Ability to work independently and collaboratively within a team environment.


This is a permanent, full-time role. Located at the affiliate office, you will need to be able to attend the Slough office on a hybrid basis.


Unable to sponsor, candidates must have full right to work in the UK and flexibility around working hours due to territories.

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