Senior Associate – Assistant Manager / Regulatory Affairs at DDReg Pharma
A rare regulatory affairs job opportunity has emerged for professionals to join DDReg Pharma as a Senior Associate – Assistant Manager. Located in Gurgaon, this full-time position offers the opportunity to manage regulatory submissions and approvals across various emerging markets. Interested candidates should apply promptly.
About the Company
DDReg Pharma is a pharmaceutical company specializing in regulatory affairs and compliance. The organization is dedicated to ensuring that pharmaceutical products meet the necessary regulatory requirements across global markets. With a focus on quality and innovation, DDReg Pharma operates in various regions, including Asia-Pacific, LATAM, and the Middle East, providing essential support for product registrations and lifecycle management.
Job Details:
- Company: DDReg Pharma
- Department: Regulatory Affairs
- Location: Gurgaon
- Reports To: Head – Regulatory Affairs / Director – Regulatory Affairs
- Posted On: 22 October 2023
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. This regulatory affairs job 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
- 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.
- 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.
- Act as the primary contact for local regulatory authorities, distributors, and regulatory consultants, supporting cross-functional coordination to ensure timely approvals and uninterrupted business operations.
Why Consider This Regulatory Affairs Job?
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Growth Opportunities
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Global Regulatory Exposure
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Learning & Development
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Cross-functional Collaboration
Join DDReg Pharma and contribute to regulatory projects supporting pharmaceutical products across diverse global markets.
Interested candidates can share their CV directly at career@ddreg.in.
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
This regulatory affairs job at DDReg Pharma is ideal for professionals looking to advance their careers in regulatory affairs. Candidates are encouraged to apply before the deadline to secure their chance to contribute to impactful regulatory projects.
