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.smailesx4lifesciences.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.