Director of Regulatory Compliance

3 days ago

mumbai, India beBeeCompliance Full time

Regulatory Affairs ManagerThis role requires a balance of strategic oversight and hands-on execution, ensuring compliance with regional regulatory frameworks while supporting business growth and product pipeline.Dossier Review and Evaluation:Review and evaluate dossiers received from manufacturers in accordance with ASEAN, Hong Kong, and country-specific registration guidelines.Ensure documentation completeness, accuracy, and adherence to local regulatory formats.Compilation and Submission:Compile dossiers for final internal review & Submit dossiers directly to country-specific regulatory authorities' online platforms as per regulatory requirements.Track submissions to ensure timely approval and lifecycle management.Communication and Coordination:Liaise with manufacturers for document revisions, data updates, and compliance alignment prior to submission.Handle regulatory deficiencies and coordinate corrective actions efficiently.Query & Deficiency Management:Address CORP and NMPA (or respective ASEAN/HK agency) queries in a professional and timely manner.Maintain clear documentation and ensure alignment of responses with company regulatory strategy.Labeling & Artwork Approval:Review and approve artworks to ensure compliance with Hong Kong's bilingual (English/Chinese) labeling standards and other ASEAN-specific requirements.Coordinate with internal design teams and manufacturers for final artwork approval before submission.Tender Support & Documentation:Prepare regulatory and compliance documents required for public tenders (Schedule B, USP/BP compliance).Coordinate sample arrangements, re-labeling, and regulatory declarations in alignment with business timelines.Regional Team Leadership:Lead, mentor, and grow the Regulatory Affairs team in India, setting clear goals, KPIs, and development plans.Oversee workload allocation, review performance, and drive accountability for results.Strategic Planning & Coordination:Develop regulatory roadmaps for new product registrations and renewals in ASEAN & HK.Plan submission schedules, monitor progress, and ensure timely completion of all regulatory milestones.Reporting & Compliance Tracking:Maintain up-to-date registration trackers and dashboards for ASEAN & HK submissions.Generate monthly/quarterly reports for senior management.The ideal candidate will have strong experience in managing end-to-end product registrations, leading teams, coordinating with global manufacturers, and driving timely submissions and approvals. A Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline is required. The selected individual must be detail-oriented, have excellent communication and coordination skills, and proficiency in Microsoft Office and submission tracking tools.A Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline is required.No specific benefits mentioned.An exciting opportunity to work with global manufacturers and lead a talented team in India.],

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