DDReg Pharma Pvt. Ltd.
Website:
ddregpharma.com
Job details:
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
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