Job Purpose:
The Asst. Manager – Regulatory Affairs (GHC/KSA) will lead regulatory strategy, submissions, and compliance for pharmaceutical products intended for the ROW markets. This is an onsite role based in Gurgaon. The individual will serve as a key regulatory liaison, ensuring products meet all regulatory requirements, supporting lifecycle management, and facilitating timely approvals by the relevant authorities.
Key Responsibilities:
- Review of eCTD/CTD dossiers, variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
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Regulatory authoring excellence: Administrative part, labelling, technical writing, formatting per GCC templates.
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Tracking and responding to Authority queries within stipulated timelines; leading cross-functional action plans.
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Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
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Collaborate with internal and external clients via project trackers.
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Demonstrate subject matter and area expertise.
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Supporting and enabling effective and efficient communication that results in operational excellence.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
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Educational Qualifications: B.Pharm / M.Pharm
Why Join Us
- Opportunity to contribute to key regulatory submissions
- Exposure to global health authority expectations
- Skill development and continuous learning environment
- Collaborative work culture