
Asst. Manager Regulatory Affairs
4 weeks ago
Compilation, preparation & review of dossiers in CTD, ACTD formats and country specific as per regulatory guidelines of countries.
Active Co-ordination with Inter department (Production, Quality Assurance, Quality Control, Packaging department and F & D) for technical data requirement.
Knowledge/Exposure of ICH Guidelines (QSEM) required for Common Technical Document (CTD) for the registration of pharmaceuticals for human use.
Preparation and review of SmPC, Package insert and labeling information.
Knowledge and file online application for dossier submission in US & EU.
Handling of query as per received from client & MOH.
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Regulatory Affairs Specialist
24 hours ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeOur client, a leading Medical Device Manufacturing company, seeks an experienced International Regulatory Affairs Executive to join their team.About the RoleThis is an exciting opportunity for a highly motivated and organized individual to work with our client's international regulatory affairs team. As an International Regulatory Affairs Executive, you will...
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Regulatory Affairs Sr. Manager
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob Title: Regulatory Affairs Sr. Manager Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Director Skills:Regulatory Compliance, FDA Regulations, Quality Assurance, Risk Management, Project Management, Communication Skills, Team Leadership, Problem Solving,Company OverviewBBioMatrix...
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Regulatory Affairs Associate
3 hours ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeInternational Regulatory Affairs Executive The International Regulatory Affairs Executive will be responsible for preparing and submitting regulatory dossiers for pharmaceutical products in Rest of the World (ROW), Asian, and African markets. Key Responsibilities: Dossier Preparation & Submission: Ensure timely preparation and submission of dossiers,...
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Regulatory Affairs Sr. Manager
2 weeks ago
Ahmedabad, Gujarat, India Biomatrix healthcare Full timeJob DescriptionCompany OverviewBBioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP,...
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Regulatory Affairs Sr. Manager
3 weeks ago
Ahmedabad, Gujarat, India Biomatrix healthcare Full timeCompany OverviewBBioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP, successfully...
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Trainee Officer Regulatory Affairs
4 weeks ago
Ahmedabad, Gujarat, India Biotech Healthcare Full timeRole Objective:The Trainee Officer – Regulatory Affairs will be responsible for assisting in the preparation, compilation, and review of regulatory documents to ensure compliance with country-specific guidelines. This role provides an opportunity to develop expertise in regulatory requirements, documentation processes, and dossier submissions, contributing...
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Trainee Officer Regulatory Affairs
4 weeks ago
Ahmedabad, Gujarat, India Biotech Healthcare Full timeRole Objective:The Trainee Officer – Regulatory Affairs will be responsible for assisting in the preparation, compilation, and review of regulatory documents to ensure compliance with country-specific guidelines. This role provides an opportunity to develop expertise in regulatory requirements, documentation processes, and dossier submissions, contributing...
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Global Regulatory Affairs Coordinator
15 hours ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeA career opportunity exists for an experienced International Regulatory Affairs Executive to join our client's regulatory affairs team in the medical device manufacturing industry.Company OverviewOur client is a leading manufacturer and exporter of urology, laparoscopy, gynecology, dialysis, cardiology, and gastrology products. They have established their...
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Regulatory Affairs Associate
1 day ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeCompany Details : Our client is an India's Largest and Leading Manufacturer and Exporter of Urology, Laparoscopy, Gynecology, Dialysis, Cardiology, and gastrology products. Their Brand Presents in More Than 85 Countries. Designation : - International RA Executive Job Profile : - The International Regulatory Affairs Executive will be responsible for...
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Regulatory Affairs Associate
1 day ago
Ahmedabad, Gujarat, India Medical Device Manufacturing Full timeCompany Details: Our client is an India's Largest and Leading Manufacturer and Exporter of Urology, Laparoscopy, Gynecology, Dialysis, Cardiology, and gastrology products. Their Brand Presents in More Than 85 Countries.Designation: - International RA Executive Job Profile: -The International Regulatory Affairs Executive will be responsible for preparing and...
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Senior Regulatory Affairs Officer
2 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob Title: Senior Regulatory Affairs Officer Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory Affairs, Quality Assurance, Regulatory Strategy Development, Class III Medical Devices, Product Registration, international legislation, accreditation requirements,...
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Senior Regulatory Affairs Officer
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob Title: Senior Regulatory Affairs Officer Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory Affairs, Quality Assurance, Regulatory Strategy Development, Class III Medical Devices, Product Registration, international legislation, accreditation requirements,...
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Regulatory Affairs Executive
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob Title: Regulatory Affairs Executive Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Skills:ROW Market, FDA Guidelines, technical documents, Review skills, Analytic Skills, Dossier Preparation,Company OverviewBioMatrix Healthcare Private Limited, 100% export-oriented...
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Senior Regulatory Affairs Executive
2 weeks ago
Ahmedabad, Gujarat, India Synerxia Healthcare Full timeJob description SYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking forposition in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission . Role and responsibilities 1.Responsible for...
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Senior Regulatory Affairs Executive
3 weeks ago
Ahmedabad, Gujarat, India Synerxia Healthcare Full timeJob descriptionSYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking for position in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission.Role and responsibilities1. Responsible...
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Senior Regulatory Affairs Executive
2 weeks ago
Ahmedabad, Gujarat, India Synerxia Healthcare Full timeJob description SYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking for position in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission . Role and responsibilities ...
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Regulatory Affairs Executive API PHARMA
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob Title: Regulatory Affairs Executive API PHARMA Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory legislation, Regulatory Permision, Regulatory Guidelines, Regulatory Inspection, Regulatory Policies, Regulatory Practise and SOP,Company OverviewSuccess Vibrant...
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Regulatory Affairs Officer
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob Title: Regulatory Affairs Officer / Sr. Officer Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Skills:ROW Market, Prepare Dossiers, Guideline Knowledge, BE Report, AMV, BMR-BPR,Company OverviewBioMatrix Healthcare Private Limited, a leading export-oriented...
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Regulatory Affairs Executive
3 weeks ago
Ahmedabad, Gujarat, India Biomatrix healthcare Full timeCompany OverviewBioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP, successfully...
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Regulatory Affairs Executive
2 weeks ago
Ahmedabad, Gujarat, India Biomatrix healthcare Full timeJob DescriptionCompany OverviewBioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP,...