Job Details

Department: Regulatory Affairs

Location: Gurgaon

Reports To: Head Regulatory Affairs / Director Regulatory Affairs

Job Summary 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.

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, and 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.

Job Category

Regulatory Affairs Disclaimer: This job posting and location has been aggregated from external source.

Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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