
Regulatory Affairs Manager
4 weeks ago
Please only apply if you can start immediately. 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 CCDS
Experience 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
-
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,...
-
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,...
-
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,...
-
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...
-
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...
-
Regulatory Affairs Specialist
4 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,...
-
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...
-
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...
-
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...
-
Regulatory Affairs Specialist
2 days ago
Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 18,00,000Regulatory affairs specialists play a vital role in ensuring compliance with regulatory requirements and facilitating the smooth operation of businesses.This position requires an individual with expertise in regulatory affairs, including experience with eCTD software and e-publishing requirements throughout the project lifecycle. The ideal candidate will...