Regulatory Affairs

2 weeks ago

Kampung Baharu Nilai, Negeri Sembilan, Malaysia Royce Pharma Manufacturing Sdn. Bhd. Full time
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.

We will become the world's most valued company to patients, customers, colleagues, investors, business partners, and the communities where we work and live.

Master's or Equivalent

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