Regulatory Affairs Manager EMEA

Competitive salary and package
 Permanent
 Berkshire
 Posted 3 years ago

Are you an experienced Regulatory Affairs professional looking for a step up in your career? If the answer is ‘yes’ then perhaps this could be the career move you are looking for!

We are working closely with a growing Pharmaceutical business with the hiring of a Senior Regulatory Affairs Manager – EMEA. Therapy areas include complex generics, respiratory and neurosciences.

Part of a wider innovative international company, the Regulatory Affairs Manager’s role is to take responsibility and execute regulatory activities across the EMEA and UK region.

Duties include:

  • 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 and Decentralised Procedure applications in the region.
  • 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.
  • Maintenance of a regulatory archive (dossiers, documents, electronic media).
  • Preparation of regular reports for regulatory and management purposes.
  • Support to the various business functions (e.g. portfolio, out licensing, launch management)
  • Proactively contribute to the strategic development of the regulatory function as a whole and hence to the successful development of the company’s commercial operations in Europe, Middle East and Africa.
  • Ensure development of procedures for compliance purposes
  • Manage or guide more junior staff when required.

To be considered for this great opportunity you must have the following experience/skills:

  • Life Sciences degree 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 is a requirement.
  • Experience in other non-EU markets in the region is an advantage.
  • Proven success in the timely management of regulatory approval procedures
  • Ability to work to deadlines and able to successfully prioritise numerous projects simultaneously.
  • Ability to work independently as well as within a team
  • Excellent verbal and written communication skills.
  • 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 etc.)
  • Ability to work in a multicultural environment.

Omega Recruitment Solutions is acting as an Employment Agency in relation to this vacancy. Omega Recruitment Solutions is an Equal Opportunities Employer. Due to a high volume of applications we will only be able to contact successful applicants within 5 working days. We may, however, contact you regarding other potential roles of interest. By applying for this position you will be agreeing to our Terms and Conditions, and Privacy Policy which can be found on our website

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