Regulatory Affairs

Duties and Responsibilities: 1. Contribute to the development and implementation of regulatory strategy for assigned projects. 2. Prepare, coordinate, manage or maintain regulatory submissions in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival). 3. Provide thoughtful & accurate comments during document review, mindful of regulatory guidance/requirements pertaining to document content. 4. Interface with external regulatory groups in the preparation/ review/ compilation /finalization/ submission/ notification of regulatory submissions. 5. Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings. 6. Monitor company progress toward fulfilment of regulatory commitments and guide on related and relevant work for regulatory department. 7. Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments. 8. Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts. 9. Develop and maintain current regulatory knowledge; provide regulatory advice for development of new / product improvement (PQI) products and other matters pertaining to regulation. 10. Involved with labelling design preparation and approval.
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Master's or Equivalent