Regulatory Affairs Specialist

3 weeks ago


Hertfordshire, United Kingdom X4 Life Sciences Full time

Exciting opportunity: Regulatory Affairs Specialist for a growing generics pharmaceutical manufacturer.


They are looking for an individual that is hard working and self-motivated to assist with all things regulatory.


Responsibilities will include:


  • Oversee all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs)
  • Assist in the preparation, compilation, and publication of documentation for the Common Technical Document (CTD) dossier.
  • Implement and communicate MA changes to relevant stakeholders, ensuring all compliance activities are effectively managed.
  • Collaborate with in-house teams, third-party designers, and contract sites to develop and update packaging artwork.
  • Create and maintain patient information leaflets and packaging components, managing artwork to ensure compliance with regulatory standards and compnay approval systems.
  • Liaise with various departments, clients, and regulatory authorities to ensure effective communication.
  • Maintain regulatory files, databases, and document chronologies, and track changes in documents submitted to agencies or partners.
  • Support New Product Development and Lifecycle Management projects.
  • Lead and/or assist in submitting licenses and authorizations for new products and modifications to existing products.
  • Prepare responses to regulatory agency inquiries to facilitate timely post-submission approvals.
  • Provide regulatory support during internal and external audits.


Competencies:

  • Bachelors degree required, ideally in sciences, engineering, medical/scientific writing, or public health administration.
  • At least 2 years of experince in Regulatory Affairs or a related field.
  • Proven experince in preparing technical documentation for regulatory submissions.
  • Strong verbal and written communication skills, with the ability to interact effectively with stakeholders.
  • Ability to work independently and manage daily regulatory responsibilities for a product portfolio.


Please share your CV at e.smailes@x4lifesciences.com if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.



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