Regulatory Specialist
5 days ago
We are seeking a highly organized and detail-orientedRegulatory Project Coordinator/Managerto be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration, dossier submissions, and market entry across various international territories. Key Responsibilities: I. Documentation & Legal CoordinationCentral Document Management:Coordinate the preparation, notarization, and Apostillization of essential legal and administrative documents, including Power of Attorneys (POAs), Letters of Authorization (LOAs), Good Manufacturing Practice (GMP) Certificates, Certificates of Pharmaceutical Product (CoPP), and Free Sale Certificates (FSC). Technical Documentation:Collaborate with the Regulatory Affairs (RA) team to compile, organize, and get technical documents (e.g., Qualitative & Quantitative (Q&Q) data) apostilled. Dispatch Management:Manage the timely preparation and dispatch of all hard-copy documents and samples to country-based regulatory teams.II. Cross-Functional Project Management HO & Country Team Liaison:Serve as the primary liaison between the HO functional teams (Legal, SCM, IT, IP, Portfolio, R&D) and country regulatory teams to facilitate support and resolve queries efficiently. Supply Chain & Sample Coordination:Coordinate with Plant QC/QA to arrange Finished Product (FP) samples and Analytical Pre-Requisites for dossier submissions. Prepare Proforma Invoices and necessary declarations for sample shipments. IP & Portfolio Support:Coordinate with IP teams on patent-related aspects and with Portfolio teams on Product Evaluation Form (PEF) and Product Information File (PIF) requirements. R&D Collaboration:Coordinate with the R&D Project Management team on DPDM (Drug Product Development Management) and CDP (Clinical Development Plan) analysis.III. Compliance, Due Diligence & Market Support Communication:Conduct regular weekly and monthly calls with country and Indian RA teams to review progress, track dossier deliveries, and address regulatory issues. Due Diligence:Perform due diligence with QC labs and R&D teams to ensure compliance with country Ministry of Health (MOH) requirements, specifically ensuring working standard qualification and stability data maintenance. Market Support:Arrange back-end regulatory support for Business Development (BD) and Marketing teams, including securing supportive documents for tender participation in Emerging Markets. Logistics:Coordinate with logistics teams for the effective dispatch of all regulatory shipments. Planning:Actively participate in the New Dossier Planning process with Regulatory teams.Experience:Proven experience 5-6 years in Regulatory Affairs, Regulatory Operations, or Project Management within the Pharmaceutical industry, preferably with exposure to Emerging Markets.Regulatory Knowledge:Strong understanding of the documentation and submission process forinternational product registration/dossiers.
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Regulatory Affairs Specialist
16 hours ago
New Delhi, India Gentell Full timeGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
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New Delhi, India Dr. Reddy's Laboratories Full timeJob SummaryWe are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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New Delhi, India Dr. Reddy's Laboratories Full timeJob SummaryWe are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Specialist
2 weeks ago
Delhi, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Specialist
2 weeks ago
Delhi, India Concept Medical Full timeAbout Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...
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Regulatory Affairs Specialist
1 day ago
Delhi, India Gentell Full timeGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
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Regulatory Affairs Specialist
2 weeks ago
Delhi, India Dr. Reddy's Laboratories Full timeJob Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Specialist
16 hours ago
New Delhi, India NexorTest Technologies Full timeLocation: Bengaluru / HybridExperience: 5 - 8 yearsOverall Package: 8 - 10 LPARole Summary:The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working cross-functionally with...
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Regulatory Affairs Specialist
4 weeks ago
New Delhi, India Biocon Biologics Full timeJob Summary:Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.Responsible for:• Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio•...
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New Delhi, India Danaher Full timeThis job is with Danaher, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and...
