Drug Regulatory Affairs

Job: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...

Company 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...

We 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...

Regulatory 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:...

We 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...

Company 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...

Title/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,...

Position : 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...

Job DescriptionThis is a remote position.From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business...

The 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...

Position: 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...

Key DeliverablesDossier compilation of initial MAA for Europe MarketResponse to EU authorities deficiencyScientific AdviceVariations and Supplements (Type IA, IA, Type IB TypeTimely review of technical and regulatory documents i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review.Hands on...

Job 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...

Key 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...

What 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...

Job 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,...

Job 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...

opportunity 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...

Position : 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...

JOB 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...