Assistant Manager- Regulatory Affairs

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 7–8 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.