
Regulatory Affairs Manager
19 hours ago
This role can be based in our Mumbai or Hyderabad Office Key Responsibilities: Preparing and reviewing product labels, leaflets, and packaging for compliance with global regulations Collaborating with cross-functional teams including regulatory, medical, and commercial Supporting product submissions, updates, and lifecycle management activities Maintaining labelling documentation and change control records Safety signal assessments, creating and maintaining CCDSExperience in providing labelling support across study phases Supporting/leading Labelling Working committee groups/ Labelling review committee Performing detailed gap analysis of Product Information against regulatory reference products, to determine highest level of safety information Authoring updates using all relevant HA guidelines and latest templates Preparing variation packages Undertaking literature reviews Post-approval activities
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Manager- Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Piramal Enterprises Full timeJob DescriptionJob Description :Business: Piramal Critical CareDepartment: Regulatory AffairsLocation: KurlaTravel: LowJob OverviewThe Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities,...
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Regulatory Affairs Specialist
2 days ago
Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,00,000Regulatory Affairs Manager Job DescriptionThe role involves developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management: Preparation, review and submission of regulatory documentation (e.g., dossiers,...
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Manager- Regulatory Affairs
4 weeks ago
Mumbai, Maharashtra, India Piramal Pharma Ltd Full timeJob DescriptionTrendingJob DescriptionBusiness: Piramal Critical CareDepartment: Regulatory AffairsLocation: KurlaTravel: LowJob OverviewThe Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities,...
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Regulatory Affairs Professional
5 days ago
Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 2,20,00,000 - ₹ 2,54,00,000Regulatory Affairs LeaderSr Manager Regulatory Affairs responsible for developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance, and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management:Preparing, reviewing, and submitting regulatory documentation to...
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Regulatory Affairs Professional
4 days ago
Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000Regulatory Affairs ProfessionalJob Overview:We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.Main...
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Regulatory Affairs Specialist
10 hours ago
Mumbai, Maharashtra, India Tek Support Full timeJob DescriptionJob Title: Regulatory Affairs Specialist Med/Pharma (Female)Location: RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities,...
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AGM Regulatory Affairs
4 weeks ago
Mumbai, Maharashtra, India NMS Consultant Full timeJob DescriptionAGM position -Regulatory AffairsB.Pharm / M.Pharm / M.Sc 12-14 years regulatory affairs experience majorly in USA market for Solid oral dosage formsKey Responsibilities:- Ensure timely submission of ANDAs, supplements and amendments- Review of registration dossiers, amendments, supplements and annual reports prepared by subordinates for...
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Regulatory Affairs Lead
3 hours ago
Mumbai, Maharashtra, India beBeeChemistry Full time US$ 8,00,000 - US$ 14,00,000Regulatory Affairs Lead PositionWe are seeking an experienced and skilled Regulatory Affairs Sub-Function team leader to oversee product registration submissions, progress reports, supplements, amendments, or periodic experience reports.Key Responsibilities:Supervise a team of professionals in directing product registration submissions, progress reports,...
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Regulatory Affairs Professional
1 week ago
Mumbai, Maharashtra, India beBeeSpecialist Full time US$ 40,000 - US$ 80,000Regulatory Affairs SpecialistThe role involves the compilation, submission and management of regulatory documentation for assigned projects.Responsibilities include maintaining accurate database records pertaining to products, in line with established systems and processes.Supporting and coordinating regulatory affairs projects, as assigned, including tender...
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AGM Regulatory Affairs
4 weeks ago
Mumbai, Maharashtra, India NMS Consultant Full timeAGM position -Regulatory AffairsB.Pharm / M.Pharm / M.Sc– 12-14 years regulatory affairs experience majorly in USA market for Solid oral dosage formsKey Responsibilities:Ensure timely submission of ANDA's, supplements and amendments Review of registration dossiers, amendments, supplements and annual reports prepared by subordinates for adequacy and...