Regulatory Affairs Specialist
4 weeks ago
Role -Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate ManagerRequired Education/Exp: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc.Key Role-Formulation Regulatory Affairs for Peptide products or InjectablesResponsibilities: Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different Health-Agencies especially for peptides products & Injectables. Prepare a regulatory submission strategy, checklist for administrative and technical documents for each submission considering country specific requirements for peptide products. Compilation of CTD sections and supporting documents from Module 1 to 5 with respect to each Health-Agencies and ensure the regulatory compliance to most current requirements. Prepare a draft response to queries raised by the Health agencies / Business partner with supporting updated documents. Ensure to respond within the prescribed timelines. Review and provide Technical inputs during product life cycle starting from developmental documents, drug-device combination product and clinical/non-clinical proposals. Co-ordinate with all cross-functional teams and regularly updating the status tracker/checklists and keep updating reporting head. Any other responsibilities vested by reporting head based on requirements.Required skills :- Hands on expertise of handling Peptide or Injectable products. Peptide Regulatory Exp will be prefered more. Well versed with regulatory guidelines.Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.comKindly mention below details whilesharing CV :-Total Exp? Current CTC? Handling exp of Peptide Regulatory or not? Notice Period? Ready to work in Bangalore (onsite) ? (5 Days working)
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Regulatory Affairs Specialist
4 weeks ago
New Delhi, India Gentell Full timeGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
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Regulatory Affairs Specialist
2 weeks ago
New Delhi, India Illusion Dental Laboratory Full timeJob DescriptionJob Title: Regulatory Affairs No of Vacancy:1 Job Location: Andheri West Years of Experience: 1-4 years Working Days: Monday to SaturdayJob Summary: We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure...
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Regulatory Affairs Specialist
1 week ago
New Delhi, India Illusion Dental Laboratory Full timeJob DescriptionJob Title: Regulatory Affairs No of Vacancy:1 Job Location: Andheri West Years of Experience: 1-4 years Working Days: Monday to SaturdayJob Summary: We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure...
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New Delhi, India MJ Surgical Full timeWe are HiringRegulatory Affairs Specialist For Medical Devices(Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA. 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Design & Development and Risk Management Files as...
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Quality and Regulatory Affairs Specialist
1 week ago
Delhi, NCR, Noida, India Saraca Solutions Full time ₹ 4,00,000 - ₹ 8,00,000 per yearWe are seeking a highly skilled Regulatory and Clinical Affairs Specialist with expertise in regulatory compliance for medical devices across the EU, India, and the US.Clinical EvolutionMedical WritingTechnical Documentation
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New Delhi, India Danaher Full timeThis job is with Danaher, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and...
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Regulatory Affairs Specialist
3 days ago
New Delhi, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing indata engineering, cloud transformations, and AI-powered analyticsfor Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.Role Overview: We are seeking aRegulatory Affairs Subject Matter Expert...
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Regulatory Affairs Specialist
23 hours ago
New Delhi, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing indata engineering, cloud transformations, and AI-powered analyticsfor Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.Role Overview: We are seeking aRegulatory Affairs Subject Matter Expert...
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Regulatory Affairs Specialist
4 weeks ago
New Delhi, India NexorTest Technologies Full timeLocation: Bengaluru / HybridExperience: 5 - 8 yearsOverall Package: 8 - 10 LPARole Summary:The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working cross-functionally with...
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Senior Compliance
4 weeks ago
New Delhi, India Hemant Surgical Industries Limited Full timeJob Title: Senior Compliance & Regulatory Affairs Specialist (Medical Devices)Location: MumbaiDepartment: Regulatory Affairs / Quality AssuranceExperience Required: 7–12+ yearsIndustry: Medical Devices / Healthcare / Pharma______________Job Summary:The Senior Compliance & Regulatory Affairs Specialist will lead and manage all activities related to BIS...
