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Regulatory Affairs
1 week ago
Hands on Electronic Operation (eCTD)E Submission GatewayBehavioral AspectsSkill RequirementsMin 5 years experience in Europe submission via DCP/MRP or NationalExperience in addressing the EU authority deficiencies satisfactorilyUnderstanding and knowledge about presentation of data in Scientific advise from EU Agencies such as BfArMThorough knowledge of EU Variations in EUKnowledge of the review of CMC/Clinical/Regulatory documentation required for submissionWorking capabilitles preferably on PharmaReady or equivalent softwareWorking capabilities on CESP Portal preferredPositive Attitude and Approach.
Learning Abilities-
Regulatory Affairs
1 week ago
Delhi, Delhi, India People First Consultants Full timeJob:Regulatory Affairs Specialist/SeniorSpecialist/Assistant Manager Experience:1012YearsSkills:The ideal candidate would have adiploma/degree in a scientific discipline such asBiology Microbiology Pharmacy pharmacology Biotechnologyengineering or medical technology. Minimum 5years of experience in Medical devices regulatory affairs and 78years of working...
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Regulatory Affairs Specialist
1 week ago
Delhi, Delhi, India ProductLife Group Full timeWe are looking for a Regulatory Affairs Specialist to join our team!Contribute to the production of client administrative documents and reports for regulatory submissionsCompile regulatory dossiers as per national requirementsDocument and track regulatory submissionsProvide support to clients and associated companiesAssess regulations and communicate their...
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Regulatory Affairs Specialist
1 week ago
Delhi, Delhi, India Apsida Life Science Full timeRegulatory Affairs Specialist - CMC Variations/Submissions 12 month contract - Immediate start Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You'll be pivotal in ensuring compliance and efficiency in our regulatory processesKey Responsibilities:CMC Change Control Assessment:...
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Regulatory Affairs Specialist
1 week ago
Delhi, Delhi, India Meril Full timeWe are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team.Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...
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Regulatory Affairs Manager
1 week ago
Delhi, Delhi, India SurgeWay Biosciences Full timeCompany DescriptionSurgeWay Biosciences Pvt Ltd is an established exporter of Pharmaceutical Drugs and Niche Healthcare Products. With a strong track record of domestic and international operations spanning 40 years, SurgeWay is led by a dynamic young team that brings a professional approach and long-term business growth outlook.Our expertise in regulatory...
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Regulatory Affairs Consultant
1 week ago
Delhi, Delhi, India Metina PharmConsulting Pvt. Ltd. Full timeCompany DescriptionWe are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore, Australia and Malaysia. We have been providing high quality & timely consulting service to the Pharmaceutical Industry in India and internationally. We have a young and...
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Drug Regulatory Affairs
1 week ago
Delhi, Delhi, India Job Provider Baddi Full timeResponsibilities: Develop and implement regulatory strategies for drug development, registration, and commercialization in compliance with local and international regulations. Coordinate regulatory submissions and responses to regulatory agencies, ensuring accuracy, completeness, and timeliness. Maintain uptodate knowledge of regulatory requirements,...
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Regulatory Affairs Executive
1 week ago
Delhi, Delhi, India Ipca Laboratories Limited Full timePosition : ExecutiveDepartment : Regulatory Affairs FormulationLocation : Kandivali West, MumbaiQualification M Sc/ B Pharm/ M PharmExperience : 4 8 years and aboveRoleResponsible for activities related to own submission and support for contract manufacturing projects of Europe marketJob Profile :To liaise with customers on matters related to their product...
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Specialist,Regulatory Affairs Digitization
1 week ago
Delhi, Delhi, India ResMed Full timeThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence...
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Regulatory Affairs Executive
1 week ago
Delhi, Delhi, India Ipca Laboratories Limited Full timePosition: Executive Department: Regulatory Affairs Location: Kandivali West, Mumbai Qualification: M Sc/B Pharm/M Pharm Experience: 4-8 years and more Role: Responsible for own submission and support for contract manufacturing projects in the European market Job Profile: Liaising with customers regarding their product licenses for implementation...
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Senior Regulatory Affairs Officer
1 week ago
Delhi, Delhi, India Aegis Lifesciences Pvt Ltd Full timeTitle/Designation:Senior Regulatory ExecutiveBased at:AhmedabadIndustry:Medical Devices manufacturing (Class III)Qualification:Postgraduate or equivalent in Pharma/Medical Devices domainExperience:5-6 years minReports to:Head of QA/RAAbout us:Aegis Lifesciences, established in 2008, is a distinguished manufacturer and exporter of medical devices,...
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Director, Public Affairs
1 week ago
Delhi, Delhi, India Copeland Full timeJob Description Copeland India is seeking a Director Public Affairs based in New Delhi. The individual will be instrumental in analysing and updating senior management on regulatory and legislative risks, opportunities and relevant laws and regulations. The individual will liaise with national, state and local government bodies, relevant industry...
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Regulatory Affairs
1 week ago
Delhi, Delhi, India Encube Ethicals Full timeKey Deliverables Dossier compilation of initial MAA for Europe Market Response to EU authorities deficiency Scientific Advice Variations and Supplements (Type IA, IA, Type IB Type Timely review of technical and regulatory documents i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review. Hands on...
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Manager - Regulatory Affairs
1 week ago
Delhi, Delhi, India Tata Consumer Products Full timeWhat are the Key Deliverables in this role ?Financial OutcomesMinimize financial impact of regulatory changes to Business through various actions/choices responses.Identify and optimize financial implications of regulatory components on product, packaging and promotions.Customer ServiceIndependently handle regulatory aspects of specific projects from concept...
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Manager - Corporate Affairs (West)
1 week ago
Delhi, Delhi, India Godrej Group Full timeJob Title:Manager – Corporate Affairs (West Region)Job Type:Permanent, Full-timeFunction:Corporate AffairsBusiness:Godrej Industries Limited and Associate CompaniesLocation:Mumbai, Maharashtra, IndiaAbout Godrej Industries Limited and Associate Companies (GILAC)GILAC is a holding company of the Godrej Group. We have significant interests in consumer goods,...
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Head Of Corporate Affairs
1 week ago
Delhi, Delhi, India Birla Opus Full timeJob Context: Head of Corporate Affairs for the Paints Business unit of Business Grasim Birla Paints, located in Mumbai. The role reports to the Business Head (President) & COO and is situated within the Corporate Affairs function and department.The job entails significant responsibilities, including obtaining statutory approvals for new manufacturing...
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Head of Corporate Affairs
1 week ago
Delhi, Delhi, India Michael Page Full timeopportunity to work with the leadership Career growth About Our Client One of the largest Automobile companies in the market Job Description Cultivate and leverage relationships with key stakeholders within government bodies such as the Ministry of Heavy Industries, Ministry of Road Transport and Highways, and industry associations like SIAM...
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Regulatory Affairs Executive
1 week ago
Delhi, Delhi, India Ipca Laboratories Limited Full timePosition : ExecutiveDepartment : Regulatory AffairsLocation : Kandivali West, MumbaiQualificationM Sc/ B Pharm/ M PharmExperience : 8 years and aboveRoleResponsible for activities related to own submission and support for contract manufacturing projects of Europe marketJob Profile :To liaise with customers on matters related to their product licenses for...
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Delhi, Delhi, India Seven Consultancy Full timeJOB DETAILS Preparation & Compilation of Dossiers in CTD/eCTD formats- good knowledge of Module Analysing and arranging the dossierArt work checkingKnowledge of ICH Guidelines- able to use Pharmacopoeia FUNCTIONAL AREA ich guideline, ctd, module 3, pharmacopoeia, Dossier, art work, analysis, Pharmaceutical industry jobs in Delhi, Pharmaceutical industry...
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Advisor, External Affairs
1 week ago
Delhi, Delhi, India Rio Tinto Full timeAdviser, External Affairs - India Be part of the world's leading mining organization Commitment to a safe working environment Support robust compliance control environments. Work with a global, diverse, and challenging team based in Gurgaon.About the roleFinding better ways to provide the materials the world needs.The External Affairs (EA) team has...