Regulatory Affairs Specialist
6 days ago
Job Description – CMC Variations Specialist Experience: 2–4 years Location:Chennai (Onsite)Key Responsibilities: Manageall types of CMC changes and variations(minor, moderate, major) as per country-specific regulatory requirements. Collaborate and communicate effectively withclient teams and stakeholdersfor data, clarifications, and approvals. Author and compile complete variation submission packages , ensuring accuracy and compliance. Review compiled packagesto verify alignment with source data and regional guidelines. Work acrossall dosage forms , including solid oral, injectables, liquids, and others. Handle submissions forEU, South Africa (SA), and Australia/New Zealand (ANZ)markets.Required Skills: Strong understanding ofglobal CMC variation requirements. Excellent documentation, communication, and coordination skills. Attention to detail and ability to work with cross-functional teams.
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Regulatory Affairs Specialist
2 weeks 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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Regulatory Affairs Specialist
3 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
3 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
2 weeks 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 Oligonucleotides
3 weeks 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 Oligonucleotides
3 weeks 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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Quality and Regulatory Affairs Specialist
2 weeks ago
Delhi, NCR, Noida, India Saraca Solutions Full time ₹ 4,00,000 - ₹ 8,00,000 per yearWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist with expertise in regulatory compliance for medical devices across the EU, India, and the US.Clinical EvolutionMedical WritingTechnical Documentation
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Regulatory Affairs Specialist
3 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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new delhi, India Danaher Full timeWondering 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 optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds,...
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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...
