Regulatory Affairs Specialist
1 day ago
This is a critical position responsible for overseeing the coordination and execution of FDA 2253 reporting submissions, serving as Digital Asset Management (DAM) librarian.
Key Responsibilities:- Conduct quality assurance reviews and process daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products.
- Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements.
- Collaborate with creative agencies and marketing teams to oversee renegotiation, renewal, and collection of usage rights for marketing materials.
- Leverage company subscriptions to provide art procurement services in support of marketing initiatives.
- Retrieve, validate, and distribute digital asset packages to agencies and marketing teams utilizing various data repositories.
- Veeva PromoMats and RIM experience.
- Proficiency in Veeva PromoMats and RIM with hands-on experience navigating the platform to manage promotional and medical content.
- Strong understanding of Veeva workflows, including initiating, reviewing, approving, and routing materials through appropriate lifecycle stages.
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Senior Regulatory Affairs Specialist
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Hyderabad, Telangana, India beBeeRegulatory Full timeJob Title: Senior Regulatory Affairs SpecialistOverviewKamet Consulting Group is a leading management consulting firm serving the life sciences industry. We are currently seeking an experienced Senior Regulatory Affairs Specialist to join our team.Key ResponsibilitiesMonitor and analyze regulatory changes, trends, and developments in the pharmaceutical and...
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Regulatory Affairs Specialist
3 weeks ago
Hyderabad, Telangana, India Thepharmadaily Full timeJob Description- Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations- Support the Global Operating Unit Regulatory Affairs function as the local representative, ensuring requirements are met- Provide regulatory support for research and development activities and ensure compliance with Indian and...
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Regulatory Affairs Expert
3 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000Senior Regulatory Specialist Job DescriptionThis role involves leading the preparation and submission of FDA 510(k) premarket notifications for medical devices. You will be responsible for preparing and reviewing regulatory documentation to ensure compliance with FDA regulations and standards.Key Responsibilities:Develop strategic plans for regulatory...
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Urgent: Regulatory Affairs Specialist
4 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title Regulatory Affairs Specialist - II-ETJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...
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Sr. Regulatory Affairs Specialist
4 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title Sr Regulatory Affairs Specialist - ET-HyderabadJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose ...
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Senior Regulatory Affairs Specialist
4 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title Senior Regulatory Affairs Specialist - SpineJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking...
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Regulatory Affairs Specialist Ii
4 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title Regulatory Affairs Specialist IIJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...
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Urgent: Regulatory Affairs Specialist
4 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title Regulatory Affairs Specialist - IIJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...
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Regulatory Affairs Expert
3 days ago
Hyderabad, Telangana, India beBeeRegulatory Full time US$ 1,54,000 - US$ 2,41,300Regulatory Affairs ExpertThe Regulatory Affairs Manager is responsible for leading the execution and coordination of global regulatory activities.Key Responsibilities:Develop and execute strategic plans for global and country-specific regulatory complianceProvide CMC regulatory strategy by defining filing requirements, submission strategies, and risk...
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Regulatory Affairs Expert Wanted
22 hours ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 7,50,000 - ₹ 12,50,000Senior Regulatory Specialist RoleWe are seeking a highly skilled and experienced professional to lead our regulatory affairs team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions.This role involves working closely with cross-functional teams to ensure compliance with regulatory...
