Assistant Manager For Regulatory Affairs (MENA market) Macleods Pharma

Macleods Pharmaceuticals; Mumbai; On-site; INR 2,000,000 - 4,000,000; Full time

Job summary

Macleods Pharmaceuticals in Mumbai seeks an experienced Regulatory Affairs professional to manage registration dossiers, respond to regulatory queries, and oversee variation filings for ROW markets.

You will coordinate with R&D and manufacturing, review technical documents for filing and commercialization, evaluate documentation from inputs, and maintain lifecycle records with proper archival in internal databases.

Qualifications

• Prepare and submit registration dossiers and renewal filings for ROW markets within deadlines.
• Coordinate responses to deficiencies or MOH queries on submitted applications.
• Review technical documents related to products under development for filing and commercialization.
• Evaluate and approve technical documentation from R&D and manufacturing.
• Review initial and updated approval packages to ensure alignment with approvals.
• Maintain lifecycle management and archiving of regulatory records in databases.

Responsibilities

• Prepare and submit registration dossiers and renewal filings for ROW markets within deadlines.
• Coordinate responses to deficiencies or MOH queries on submitted applications.
• Review technical documents related to products under development for filing and commercialization.
• Evaluate and approve technical documentation from R&D and manufacturing.
• Review initial and updated approval packages to ensure alignment with approvals.
• Maintain lifecycle management and archiving of regulatory records in databases.

Job description

Role & responsibilities

• 1. Ensure timely preparation and submission of registration dossiers, responses to Ministry of Health (MOH) queries, renewal applications, and variation filings for Rest of World (ROW) markets in accordance with predefined timelines.
• 2. Coordinate and finalize responses to deficiencies or queries raised by regulatory authorities on submitted applications.
• 3. Review technical documents related to products under development, for filing and commercialization purposes.
• 4. Evaluate and approve technical documentation received from R&D and manufacturing units.
• 5. Review initial and updated approval packages to ensure alignment with granted approvals.
• 6. Maintain lifecycle management activities and ensure proper archival of regulatory documentation in internal databases

Preferred candidate profile

Exp- 10 to 15 yrs experience in Regulatory Affairs- ROW market