Assistant Manager - Regulatory Affairs API @ Hetero

Job Description

Key Responsibilities: Prepare and compile Drug Master Files (DMFs) for China in compliance with regulatory guidelines. Conduct thorough reviews of technical and regulatory documentation to ensure accuracy and compliance. Prepare and submit responses to deficiency letters (DL) from regulatory authorities. Manage the entire regulatory life cycle of API products, including updates, renewals, and variations. Work closely with internal teams (R&D, Quality, Manufacturing) and external regulatory agencies to ensure smooth approvals and compliance. Maintain up-to-date knowledge of global regulatory requirements and ensure adherence to the latest guidelines. Skills Strong understanding of global regulatory guidelines, especially China requirements. Ability to analyse and interpret regulatory requirements with precision. Excellent written and verbal communication to effectively interact with regulatory authorities and internal stakeholders. Proactive approach to identifying regulatory challenges and developing solutions. Educational Qualification: M.Pharm / B.Pharm / M.Sc. in Chemistry or a related scientific discipline. Experience: 5-10 years of experience in Regulatory Affairs (API) with hands-on expertise in China DMF compilation, review, and submission.,

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Keyskills:   verbal communication