You will be responsible for maintaining our Quality Management System (QMS), handling batch release activity and working with the team in preparation of technical files in line with regulatory guidelines.Provident fundJob Cl...

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration.Dossier compilation as per guidelines.Compilation and review the product dossiers for submission in CTD, ACTD.Gap analysi...

Ensure ComplianceCommunication with Regulatory AgenciesDrug Development SupportSubmitting product registration dossiers, clinical trial documentationCOPP product wise approvalAuditRequired Candidate profileQualification B. Ph...

Preparation of DMFs for different markets in CTD and eCTD formats.Coordination with cross-functional dept to manage the documents.Supporting marketing team & QC/QA/R&D in various capacity.Preparation of Declarations a...

Exp.: Min 4 to 5 yearsDesignation: Executive- Regulatory AffairsLocation: MumbaiMust have Key Skills: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ RenewalsOther essential skills: LATAM/ GCC/ MENA/ SEA/A...

1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO14971:2012 & ...

We are seeking a diligent Regulatory Affairs Executive to support our compliance efforts, ensuring adherence to FSSAI, Legal Metrology, and AYUSH regulations. The successful candidate will play a key role in preparing and sub...