Assistant Manager - Regulatory Affairs

Position Details:

Designation: Assistant Manager - Regulatory Affairs CMC

Location: Navi Mumbai

Reporting to: Deputy General Manager

Job Summary:

The Assistant Manager Regulatory Affairs will be responsible for managing and coordinating regulatory submissions for the US, EU, and Canadian markets, ensuring compliance with applicable regulations (FDA, EMA, Health Canada). The role involves preparing, reviewing, and submitting high-quality regulatory dossiers (NDA, ANDA, MAA, ANDS, etc.) and maintaining effective communication with health authorities/Regulatory Counterparts.

Overall Job Responsibilities:

1. Regulatory Submissions

• Prepare, review, and submit high-quality regulatory dossiers (eCTD format) for new product approvals (NDA, ANDA, MAA, NDS, etc.) in the US, EU, and Canada.
• Ensure compliance with FDA (21 CFR), EMA, ICH, Health Canada, and other relevant regulatory guidelines.
• Lead and support responses to health authority queries (IRs, CRL/EU and CA deficiencies) in a timely manner.
• Drafting of Controlled correspondence/Scientific Advice to the USFDA, Health Canada and EU agencies.

2. Regulatory Strategy & Planning:

• Develop and execute regulatory strategies for new product submissions and deficiency response
• Conduct regulatory assessments for new products and provide guidance on submission pathways to R&D and other cross functional teams
• Monitor regulatory changes and assess their impact on product development and submissions.
• Maintain and update regulatory files, databases, and tracking systems for submissions.
• Ensure proper archival of regulatory documents and correspondence.

Qualification & Skills:

Education: Master’s in Pharmacy

Experience/Skills

• 8-12 years in Regulatory Affairs (US, EU, and Canada markets).
• Hands-on experience in preparing ANDA/NDA/MAA/NDS submissions.
• Knowledge of eCTD, CDER/EMA/Health Canada guidelines.
• Strong project management and analytical skills.
• Excellent communication and stakeholder management.
• Proficiency in regulatory eCTD software