GxP, GLP, Regulatory Environments Support Analyst

Position - GxP Manual Functional TesterLocation - Pune/NagpurDuration - Full timeOffice Hours: India/UK TimeMinimum 5+ years of experience in manual testing in GxP-compliant environmentsGood understanding of STLC, Functional testing, FIT, UAT, Defect ManagementHands on experience in FIT Test case design and executionsHands on experience in UAT test...

About the Role:We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems...

About The Role :  Job TitleRegulatory Operations Analyst LocationPune, India Role Description As part of the COO function, the Global Reporting & Performance Measurement department is responsible for the provision of client-specific and regulatory reports for the entire DWS Active, Passive & Alternatives business area.- As Operation Analyst in the...

About the Role: We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems...

Location: Pune, Maharashtra Reports To: General ManagerCompany Overview: Auxilife is a leading agrochemical research and regulatory solutions provider, focused on developing innovative crop protection products while ensuring compliance with regulatory requirements globally.Position Summary: The Assistant Manager – Regulatory & Toxicology will support...

Role & responsibilitiesRole Overview:The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission. Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory...

Location: PuneEmployment Type: full-timeDesignation: Business Data AnalystJob DetailsJob Title: R&D IT Business Data AnalystPosition Summary:We are seeking a highly motivated and detail-oriented R&D IT Business Data Analyst to serve as a critical liaison between IT, R&D, and cross-functional teams in the Biotech Industry. This role supports the integration...

The Apex Group was established in Bermuda in 2003 and is now one of the world's largest fund administration and middle office solutions providers.Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745).Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers.Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing...

1. Regulatory Affairs: -o Prepare, compile, and submit regulatory dossiers (e.g., CIBRC, CDSCO, EU, etc.) for registration of agrochemical, disinfectants, biocide and food contact material products.o Liaise with client and regulatory authorities for approvals, clarifications, and queries.o Maintain up-to-date knowledge of regulatory requirements in India and...