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.