Regulatory Affairs Specialist –
2 weeks ago
Key Responsibilities:Regulatory Submissions & ComplianceAuthor, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD.Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).Coordinate responses to health authority queries through cross-functional collaboration and data collation.Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.Project Planning & ManagementManage regulatory submissions for multiple products across multiple countries simultaneously.Utilize project management tools to track project milestones, timelines, and deliverables.Ensure efficient time and resource allocation to meet submission deadlines.Foster seamless communication between central regulatory, regional teams, and client stakeholders.Requirements:8–10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets.Strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent cross-functional communication and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.
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Regulatory Affairs Specialist
3 weeks ago
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
5 days ago
Noida, India Gentell Full timeJob Description Gentell 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...
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▷ [Urgent] Regulatory Affairs Specialist
2 weeks ago
Gurugram, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Specialist Job Description Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist - ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added...
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Regulatory Affairs Operations Specialist
3 weeks ago
Pune, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: - International Registrations - Upload, Verify, and Validate the data with new Regulatory Information to the RIM database - Maintain Registration &Licensing Information - Create Submission Packages for International Registrations - Initiate Renewals with...
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India G&L Scientific Full timeWe are seeking three Global Regulatory Affairs Specialists to provide critical subject matter expertise and backfill internal SMEs during a major regulatory transformation initiative. These roles will ensure continuity of day-to-day regulatory operations - particularly across CMC, labelling, and lifecycle management activities. This opportunity can be...
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Regulatory Affairs Associate
1 week ago
India Cisbio Full time**Responsibilities**: Location India - Remote, IN Job ID JR-031455 PerkinElmer is a global technology company focused on improving the health and safety of people and the environment. The Regulatory Affairs Specialist will support our Diagnostics Business that focuses on products targeted to improve human health. He/she will support regulatory submissions...
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Senior Compliance
7 days ago
India Hemant Surgical Industries Limited Full timeJob Title: Senior Compliance & Regulatory Affairs Specialist (Medical Devices) Location: Mumbai Department: Regulatory Affairs / Quality Assurance Experience Required: 7–12+ years Industry: Medical Devices / Healthcare / Pharma ______________ Job Summary: The Senior Compliance & Regulatory Affairs Specialist will lead and manage all activities related to...
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Regulatory Specialist and Senior Specialist
7 days ago
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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Senior Compliance
5 days ago
Mumbai, India Hemant Surgical Industries Limited Full timeJob Description Job Title: Senior Compliance & Regulatory Affairs Specialist (Medical Devices) Location: Mumbai Department: Regulatory Affairs / Quality Assurance Experience Required: 712+ years Industry: Medical Devices / Healthcare / Pharma ______________ Job Summary: The Senior Compliance & Regulatory Affairs Specialist will lead and manage all activities...
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[3 Days Left] Regulatory Affairs Specialist
3 weeks ago
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...
