Executive Regulatory Affairs – Global Submissions & Compliance

Sun Pharmaceutical Industries, Inc.; Indiana (PA); On-site; USD 8,300 - 15,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Panoli seeks an Executive – Regulatory Affairs to manage GMP documentation, coordinate regulatory submissions, and ensure compliance across global markets.

The role requires 4–6 years of regulatory experience and a relevant postgraduate degree (M.Pharm/M.Sc). You will review documentation, support DMF submissions, and collaborate with RA teams to maintain timelines and quality.

Qualifications

• Minimum M.Pharm or M.Sc in a related field.
• 4–6 years of relevant regulatory affairs experience.
• Experience with GMP documentation and audits.
• Knowledge of DMF/USDMF submissions and global regulatory requirements.

Responsibilities

• Review and maintain GMP documents.
• Coordinate QMS activities (Change Control etc.).
• Approve documents like SOPs, STPs, etc.
• Review, follow up and compile data for USDMF/CEP/DMF submissions (New DMF) and amendments; Mumbai.
• Review, follow up and compile data for DMF amendments; Gurgaon.
• Compile data for submissions in Japan, China, TGA, Canada; coordinate ROW data; Mumbai.
• Coordinate and organize plant regulatory team for planning and execution.

Skills

Regulatory affairs

GMP compliance

Documentation management

Cross-functional coordination

Education

M.Pharm/M.Sc

Job description

Sun Pharmaceutical Industries Ltd in Panoli seeks an Executive – Regulatory Affairs to manage GMP documentation, coordinate regulatory submissions, and ensure compliance across global markets.

The role requires 4–6 years of regulatory experience and a relevant postgraduate degree (M.Pharm/M.Sc). You will review documentation, support DMF submissions, and collaborate with RA teams to maintain timelines and quality.