Job Detail
Detail of Job
Manager Regulatory
Karachi,
Pakistan
Department/Field
Regulatory Affairs
Experience Detail
8-14 years
Job Description
"Maintain contact with local DRAP & International Regulatory authorities (for major markets) while maintaining an open channel for advocacy. Develop a forum where claims can be evaluated in partnership with Marketing & BD for each geography. Keep track for emerging regulatory requirements, monitoring impact of chain regulations on submission strategies and update internal stakeholders. Create a liaison between international regulatory and local BD and Marketing for innovation ideation. Coordinate, manage and maintain Nutraceutical registration application submissions and approvals in Pakistan and International countries in accordance with applicable guidelines. Review & monitor submission of pre-approval compliance responses to the relevant regulatory authority; Evaluate and assess the acceptability, quality & clinical documentation to secure submission approval. Develop and monitor systems to ensure development, review and approval of labeling components in compliance with country specific labeling guidelines and/or requirements and labeling policy/SOP. Assist in regulatory audits by WHO and International Regulatory Bodies. Plan and finalize new product application submissions for exporting countries. Interface with external regulatory groups (distributors, CROs, consultants) in the finalization of regulatory submissions action plan. "