Regulatory Affairs Specialist

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.