Regulatory Specialist
1 day ago
We are seeking a highly organized and detail-oriented Regulatory Project Coordinator/Manager to 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 Coordination- Central 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 for international product registration/dossiers.
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Senior Regulatory Affairs Specialist
2 days ago
Hyderabad, Telangana, India Dyaz Innovate Full time ₹ 8,00,000 - ₹ 24,00,000 per yearCompany DescriptionDyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment.Role DescriptionThis is a full-timeon-siterole for a Senior Regulatory...
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Regulatory Affairs Specialist
3 days ago
Hyderabad, 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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Sr. Regulatory Publishing Specialist
1 day ago
Hyderabad, Telangana, India Makro Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Title: Senior Regulatory Publishing SpecialistResponsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with...
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Specialist II, Regulatory
2 days ago
Hyderabad, Telangana, India Velocity Clinical Research Full time ₹ 40,00,000 - ₹ 1,20,00,000 per yearOverviewVelocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We...
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Hyderabad, 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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Hyderabad, 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 Oligonucleotides
12 hours ago
Hyderabad, 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
Hyderabad, Telangana, India Medtronic Full time ₹ 5,00,000 - ₹ 12,00,000 per yearAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeRegulatory Affairs Specialist In this exciting role as a Regulatory Affair Specialist, you will...
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Regulatory Affairs Specialist Oligonucleotides
4 hours ago
Hyderabad, India Whatjobs IN C2 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 Specialist
1 day ago
Hyderabad, India MSN Laboratories Full timeWe are seeking a highly organized and detail-oriented Regulatory Project Coordinator/Manager to 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,...
