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.
