Regulatory Affairs Manager

Job Description: Regulatory Affairs – OSD (ROW Markets) Designation- Officer/Executives/AM/Manager/Sr Manager Total Roles-10 Location: Navi Mumbai Experience: 5 to 18 years Industry: One of the Top Pharmaceutical Company having turnover 10,000 Cr + Domain: Regulatory Affairs – Oral Solid Dosage (OSD) Market Focus: Rest of the World (ROW) Key Responsibilities:

• Prepare, review, and submit regulatory dossiers for Oral Solid Dosage (OSD) products in ROW markets.
• Ensure compliance with country-specific regulatory requirements and guidelines.
• Handle end-to-end regulatory submissions, including new product registrations, renewals, and post-approval changes.
• Liaise with international regulatory agencies and maintain updated knowledge of evolving regulatory landscapes.
• Work closely with cross-functional teams, including R&D, Quality, Manufacturing, and Supply Chain, to ensure regulatory compliance.
• Manage regulatory queries and deficiency responses from health authorities in a timely manner.
• Evaluate and implement regulatory strategies for product lifecycle management.
• Ensure compliance with ICH, WHO, and other regulatory guidelines applicable to ROW markets.

• Education: M.Pharm / B.Pharm / M.Sc in a relevant field.
• Experience: 5 to 15 years in Regulatory Affairs for Oral Solid Dosage (OSD) formulations.
• Industry: Experience working with top pharmaceutical companies handling ROW markets.
• Strong knowledge of regulatory requirements in ROW countries, including dossier preparation (CTD/eCTD).
• Preferred to have experience for China , South Africa market
• Hands-on experience with product registrations, renewals, and variations.
• Excellent communication and documentation skills