(High Salary) Assistant Manager- Regulatory Affairs

18 hours ago


Mumbai, India Domnic Lewis Private Limited Full time

Job Description We are looking for an Assistant Manager- Regulatory Affairs and Pharmacovigilance for a Global Pharmaceutical MNC based in BKC, Mumbai Position: Assistant Manager- Regulatory Affairs (Domestic market) Experience: 7+ in Regulatory affairs for domestic market Location: BKC, Mumbai Purpose of the Role: Ensure the highest professional standards in Regulatory Affairs and Pharmacovigilance to align with business objectives, values, and regulatory compliance. Key Responsibilities: - Maintain and upload data to Health Authority databases (e.g., SUGAM, FDA). - Compile and submit applications for product registration (drugs, medical devices, food supplements). - Handle CMC (Chemistry, Manufacturing, and Controls) queries and lifecycle management, including labeling, license renewals, and artwork reviews. - Develop and implement regulatory strategies for export markets and ensure compliance with CDSCO and international regulations. - Support inspections, audits, and internal Quality Management Systems (QMS). - Manage product complaints, recalls, and suspected falsified products. - Maintain global and local regulatory databases. Profile Requirements: - Qualifications: B.Pharm/M.Sc. with 78 years of experience; MBBS/M.Pharm/Ph.D. (preferred). - Skills: Strong understanding of CMC, non-clinical, and clinical data; proficiency in MS Office; excellent communication and organizational skills. - Competencies: Knowledge of regulatory requirements, drug development, risk-benefit analysis, adaptability, and teaching ability. Key Attributes: Professional discretion, ability to work independently, attention to detail, and enthusiasm for maintaining high standards in regulatory and pharmacovigilance activities.



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