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 :

Key Attributes :

Professional discretion, ability to work independently, attention to detail, and enthusiasm for maintaining high standards in regulatory and pharmacovigilance activities.

Skills Required

Regulatory Compliance, Data Analysis, Clinical Trials, Quality Assurance, Risk Management