Asst-Manager RA_ ASEAN_(Onsite)_ (5+yrs Exp)

DDReg Pharma
DDReg Pharma Full Time Gurgaon Posted 6 hours ago Job Purpose:
The Asst. Manager – Regulatory Affairs (ASEAN) 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. Regulatory authoring excellence: Administrative part, labelling, technical writing, formatting per GCC templates.
Tracking and responding to Authority queries within stipulated timelines; leading cross-functional action plans. Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence. Collaborate with internal and external clients via project trackers. Demonstrate subject matter and area expertise. 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. 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 Related Blog Post Job Features Job Category Regulatory Affairs