Regulatory Affairs Manager

4 weeks ago


Slough, United Kingdom Blackfield Associates Full time

Our client, a global pharmaceutical company which develops a portfolio of prescription generic and branded pharmaceuticals within the CNS, Neurology and respiratory areas.


As Regulatory Affairs Manager, you will:

  • Preparation, submission, and management of variation applications to agreed timelines
  • Manage and submit Renewals and PSURs in line with specified timelines.
  • Preparation, submission, and management of approvals of National, Mutual Recognition, Decentralised and Centralised Procedure applications in the region- MRDCP
  • Preparation and maintenance of the product information SmPC/PIL.
  • Management of all regulatory activities related to the UK and EU markets (including artwork approvals, maintenance of Manufacturer’s / Importer licence (MIA) etc.)
  • Record data in relevant regulatory database.
  • Ensure development of procedures for compliance purposes


To be considered for the role of Regulatory Affairs Manager, you will have the following experience and skills:

  • Educated to degree level in relevant Life Sciences field or equivalent is essential.
  • An in-depth understanding and experience of EU regulatory requirements including marketing authorisation submissions and maintenance activities on a European level.
  • Experience working in a UK affiliate for Generic pharma is essential
  • Experience in other non-EU markets in the region is an advantage.
  • Able to demonstrate working cross functionally, such as implementing strategy
  • IT skills at an advanced level (Excel and other MS Office tools, various Regulatory Affairs Information Systems such as eCTD publishing tools, databases and tracking systems, CESP, MHRA portal, etc.)
  • Able to work hybrid, with weekly presence in the Slough office
  • Have the right to work without the need for sponsorship
  • Only applicants who have worked in Generic Pharma on a permanent basis will be considered.
  • Not open to Contractors / Freelancers.


This is a permanent position, which alternates between 3 days and 2 days per week onsite.


For more information or to discuss this opportunity, please contact Rob Carnell at Blackfield Associates.



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