Regulatory Affairs Specialist Lead

2 days ago


Hertfordshire, United Kingdom X4 Life Sciences Full time
Job Overview

X4 Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to oversee the lifecycle maintenance of registered Marketing Authorizations (MAs) for our growing generics pharmaceutical portfolio.

The ideal candidate will have at least 2 years of experience in Regulatory Affairs or a related field, with a proven track record of preparing technical documentation for regulatory submissions.

This role offers a competitive salary of $85,000 - $110,000 per year, depending on experience, and opportunities for career growth in a dynamic and innovative company.

Key Responsibilities
  • Oversee all aspects of MA lifecycle maintenance, including preparation, compilation, and publication of documentation for the Common Technical Document (CTD) dossier.
  • Assist in implementing and communicating MA changes to relevant stakeholders, ensuring effective management of compliance activities.
  • Collaborate with in-house teams, third-party designers, and contract sites to develop and update packaging artwork, patient information leaflets, and packaging components.
  • Liaise with various departments, clients, and regulatory authorities to ensure effective communication and maintain regulatory files, databases, and document chronologies.
Requirements
  • Bachelor's degree in sciences, engineering, medical/scientific writing, or public health administration required.
  • At least 2 years of experience in Regulatory Affairs or a related field.
  • 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.


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