Regulatory Affairs Specialist for a growing generics pharmaceutical manufacturer sought. Responsibilities include lifecycle maintenance for registered Marketing Authorizations, CTD dossier preparation, MA changes, packaging artwork development, patient information leaflets, and regulatory file maintenance.
* Oversee MA lifecycle maintenance
* Prepare and publish CTD dossier documentation
* Implement and communicate MA changes
* Develop and update packaging artwork
* Create and maintain patient information leaflets
* Liaise with departments, clients, and regulatory authorities
* Maintain regulatory files and databases
* Support New Product Development and Lifecycle Management projects
* Lead and/or assist in submitting licenses and authorizations
* Prepare responses to regulatory agency inquiries
* Provide regulatory support during audits
* Bachelors degree in sciences, engineering, medical/scientific writing, or public health administration
* At least 2 years of experience in Regulatory Affairs or a related field
* Proven experience in preparing technical documentation for regulatory submissions
* Strong verbal and written communication skills
* Ability to work independently and manage daily regulatory responsibilities
Interested candidates should share their CV at e.smailes@x4lifesciences.com. Referral bonus offered for successful placements.