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 career@ddreg.in