Regulatory Affairs Officer
1 week ago
Assist in the preparation and review of regulatory dossiers in CTD/eCTD formatfor submission.Support in the compilation of documentation for New MarketingAuthorizations, Post -Approval Variations, and Renewals.Coordinate with departments such as QA, QC, Production, R&D, andPackaging for data collation and timely submission.Review and verify product labeling, SmPCs (Summary of ProductCharacteristics) and artworks as per MHRA requirements.Track and manage regulatory submission timelines and maintain regulatorysubmission records.Assist in compiling response packages for deficiency letters / queries fromMHRA.Support audits and inspections by MHRA by providing required regulatorydocumentation.Maintain awareness of changes in regulatory guidelines and communicateupdates internally
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Executive Officer Drug Regulatory Affairs
6 days ago
Panchkula, India Venus Remedies Full timeExecutive Officer Drug Regulatory Affairs (DRA) Job Posting: 10/11/2021 Panchkula JOB REQUIREMENTS Mandatory Qualifications Work Experience in Relevant Field 2.5-5 Years Technical Skills Required Who You'll Work With Regulatory Authorities What You'll Do Registration of new pharmaceutical drug Product.Renewal of approval of existing drug products....
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Regulatory Affairs Executive
6 days ago
Panchkula, India cosmetify Full time**Job description** 1.Prepare and submit regulatory documents with Food and Drug Administration for product approvals and renewals 2. Maintain up-to-date knowledge of regulatory requirements, guidelines, and industry trends. 3. Maintaining BMR and BPR records 4. Checking and approving Products artwork 5. Support regulatory inspections and audits,...
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Drug Regulatory Affairs Executive
2 days ago
Panchkula, Haryana, India Venus Remedies (VRL) Full time ₹ 15,00,000 - ₹ 25,00,000 per yearRole & responsibilitiesJob Summary:We are looking for a skilled and motivated Senior Executive Drug Regulatory Affairs to support the registration and maintenance of injectable pharmaceutical products across ROW (Rest of the World) markets. The ideal candidate will have experience in compiling and submitting dossiers in accordance with country-specific...
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Regulatory Affairs Specialist
2 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
1 week ago
India, Maharashtra, Govandi USV Full time ₹ 12,00,000 - ₹ 36,00,000 per yearear Candidate,We are seeking a Senior Executive/ Assistant - Regulatory affairs Europe) to join our team, He/ she will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approvals. based at Govandi Location.Markets : EuropeDosage Form : OSD/ SterileKey Responsibilities:● Collate/prepare and file dossiers in...
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▷ [Urgent] Regulatory Affairs Specialist
1 week 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 Manager I
3 weeks ago
Bengaluru, India AstraZeneca Full timeJob Description Job Title: Regulatory Affairs Manager I Global Career Level: D1 Introduction To Role Are you ready to be part of a team that transforms drug development strategies into reality The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...
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Regulatory Affairs
1 week ago
Karnataka, , India Dognosis Full time ₹ 6,00,000 - ₹ 18,00,000 per yearAt Dognosis, we're redefining early disease detection by combining the olfactory brilliance of trained canines with neuroscience and AI. As we work toward building the world's most advanced canine -assisted early cancer detection system, we are seeking a Regulatory Affairs & Quality Associate to support our ISO 17025 accreditation and ongoing compliance...
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Regulatory Affairs Operations Specialist
2 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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Analyst Regulatory Affair
3 weeks ago
India Dr. Reddy's Laboratories Full timeCompany Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20 employees...