Assistant Manager- Regulatory Affairs

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.