Regulatory Affairs Specialist

Routine support and collaboration with the Head of Global Regulatory Affairs in administrative activities related to submissions and technical preparation of dossiers.
Maintain compliance with post-marketing commitments and maintenance of licenses/authorizations for existing products, including review/approval of internal specifications, evaluation of changes in product or processes to determine regulatory impact
Support in the preparation and management of technical documentation for regulatory submissions in a timely manner.
Review documentation intended for regulatory submissions to ensure relevant regulatory requirements are met.
Responsibility for approval and modifications of packaging materials.
Collaborate and share knowledge with cross-functional teams such as R D, QA, QC and supply chain.