Senior Associate Assistant Manager Regulatory Affairs Emerging Markets

DDReg Pharma Pvt. Ltd.; Gurugram District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

DDReg Pharma Pvt. Ltd.

in Gurgaon seeks a Senior Associate – Assistant Manager / Regulatory Affairs (Emerging Markets) to manage regulatory submissions, approvals, and lifecycle activities across Asia-Pacific, ASEAN, LATAM, CIS, Middle East, Africa and other markets. You will prepare dossiers in CTD/eCTD format, coordinate with CMC, QA, Manufacturing and Pharmacovigilance, liaise with authorities, and ensure timely registrations, renewals and label changes.

Qualifications

• Experience in preparing regulatory dossiers for multiple markets.
• Ability to manage regulatory submissions and life-cycle activities.
• Strong understanding of CTD/eCTD formats and country-specific requirements.

Responsibilities

• Develop regulatory strategies for registrations, renewals, variations and line extensions.
• Coordinate with internal teams to gather regulatory documentation.
• Submit dossiers and monitor approval timelines across Emerging Markets.
• Act as liaison with regulatory authorities and respond to queries.

Skills

Regulatory submissions

Dossier preparation

Regulatory compliance

Agency liaison

Cross-functional coordination

Lifecycle management

CTD/eCTD

Job description

Job Description:

Department: Regulatory Affairs

Location: Gurgaon

Reports To: Head – Regulatory Affairs / Director – Regulatory Affairs

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.

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.