Department: Regulatory Affairs

Location:
Gurgaon Reports To: Head – Regulatory Affairs / Director – Regulatory Affairs Job Purpose The Senior Associate – Assistant Manager / Regulatory Affairs (Emerging Markets) will be responsible for managing regulatory submissions, approvals, and lifecycle management activities across Emerging Markets, including Asia-Pacific, ASEAN, LATAM, CIS, Middle East, Africa, and other global markets. The role requires expertise in dossier preparation, product registrations, regulatory compliance, regulatory agency liaison, and cross-functional coordination to ensure timely approvals and uninterrupted business operations.

Key Responsibilities
Regulatory Strategy & Compliance
• Develop and execute regulatory strategies for product registrations, renewals, variations, and line extensions across Emerging Markets.
• Ensure compliance with country-specific regulatory requirements, guidelines, and pharmaceutical regulations.
• Assess regulatory risks and recommend mitigation plans for successful registrations and product launches.
• Monitor regulatory changes and communicate their impact to internal stakeholders. Product Registration & Lifecycle Management
• Prepare, review, compile, and submit registration dossiers in CTD/eCTD and country-specific formats.
• Manage lifecycle activities including:
• Variations/Amendments
• Renewals
• Site Transfers
• MAH Transfers
• Labeling Changes
• Product Withdrawals




• Coordinate timely approvals to support commercial and supply chain objectives.
• Maintain registration status and approval trackers for assigned markets. Dossier Preparation & Submission Management
• Coordinate with CMC, Quality Assurance, Manufacturing, Clinical, Pharmacovigilance, and Supply Chain teams to obtain regulatory documentation.
• Review Module 1 and country-specific submission requirements.
• Ensure completeness and quality of dossiers before submission.
• Support electronic submissions wherever applicable. Regulatory Agency Interaction
• Act as the primary contact for local regulatory authorities, distributors, and regulatory consultants.
• Coordinate responses to agency queries, deficiency letters, and information requests.
• Ensure timely closure of regulatory commitments and approvals.
• Support inspections, audits, and regulatory meetings when required. Labeling & Artwork Management
• Review and approve product labeling, package inserts, artworks, and promotional materials as per local market requirements.
• Coordinate implementation of approved labeling changes with internal and external stakeholders.
• Ensure compliance with local language and country-specific labeling regulations. Why Join DDReg Pharma? Growth Opportunities Global Regulatory Exposure Learning & Development Cross-functional Collaboration Join DDReg Pharma and contribute to regulatory projects supporting pharmaceutical products across diverse global markets. Or you can share your CV directly at [email protected] Related

📌 Senior Associate – Assistant Manager (Gurugram)
🏢 DDReg Pharma
📍 Gurugram