Senior Associate

DDReg Pharma

Quality Driven by Passion

Full Time

Gurgaon

Posted 5 hours ago

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

Job Features

Job Category

Regulatory Affairs