Regulatory Affairs Specialist
3 weeks ago
Core Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products. Ensure timely submissions and approvals for all regulatory filings. Evaluate technical and scientific data for regulatory submissions. Liaise with health authorities for inspections, clarifications, and approvals. Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs. Product & Business Support Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution. Provide regulatory support for internalization and externalization of products. To provide site CMC documents to international business team to support export registration. Documentation & Quality Oversight Maintain and update regulatory databases, trackers, licenses, and approvals. Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications. Evaluate and approve site change controls and Change Request evaluation forms. Provide working standards/specifications and CoAs to regulatory authorities and internal teams. Tender Certificates To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business. Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority. Governance, SOPs & Training Support the preparation, revision, and implementation of Regulatory SOPs and work instructions. Deliver training on GMP, regulatory updates, and SOPs at the site level. Approve SCNs from Corporate QA and review reports from regulatory authorities. Additional Responsibilities Complete assigned trainings on time Perform other duties as assigned by the Regulatory Affairs leadership. Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations. Position Accountability/Scope: · Responsible for all regulatory activities for the manufacturing site mainly LL sites. · Ensures site compliance with applicable national regulations and Abbott standards. Supports business continuity through proactive regulatory planning and execution.Minimum Education: B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.Minimum Experience/Training Required: GOA FDA Mandatory Manager:Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable. Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
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Regulatory Affairs Specialist
5 days 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
5 days 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
4 weeks ago
New Delhi, India Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation:At Ahmedabad Office , Near Thaltej Crossroads Department:RA Reports To:RA Head and Regulatory Department at HO /Director Employment Type:Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday andSaturday Half Day Preferred Gender: M/F Experience : Minimum 2 yearsJob Summary: We are seeking a proactive...
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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 Oligonucleotides
20 hours ago
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
5 days 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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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...
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Regulatory Affairs Specialist
2 weeks ago
New Delhi, India Shiv Nadar School Full timeJob Title: Senior Manager – Regulatory Affairs & Legal CompliancesLocation: Core Office, NoidaEmployment Type: Full-timeJob Summary:We are seeking a detail-oriented and proactive professional to oversee the organization’s legal, regulatory, and compliance functions. The incumbent will be responsible for ensuring adherence to statutory requirements,...
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Regulatory Affairs Specialist
2 weeks ago
New Delhi, India Shiv Nadar School Full timeJob Title:Senior Manager –Regulatory Affairs & Legal Compliances Location:Core Office, Noida Employment Type:Full-timeJob Summary: We are seeking a detail-oriented and proactive professional to oversee the organization’s legal, regulatory, and compliance functions. The incumbent will be responsible for ensuring adherence to statutory requirements,...
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Regulatory Affairs Specialist
2 days ago
Delhi, Delhi, India Masimo Full time ₹ 5,00,000 - ₹ 12,00,000 per yearThe primary role for the Regulatory Affairs Specialist is to manage end to end Regulatory Submissions & Compliance for Masimo India teamPrepare, draft, and compile 510(k)/any other applicable Premarket Notifications and related FDA submissions.Support domestic and international product filings and registrations, including maintenance of EU Technical Files,...
