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Reqd Regulatory Affairs - Sr Officer/Exe- Pharma API Business

Reqd Regulatory Affairs - Sr Officer/Exe- Pharma API Business

Exemed

3 - 5 years

3 - 5 Lacs

Vadodara

Posted:2 months ago| Platform:

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Skills Required

Regulatory Guidelines New Drug Applications SND ICH USFDA APIs. CDSCO RA impurity profiling Characterization Regulatory Affairs Dossier EMA global regulatory guidelines API Chemistry Characterization Nitrosamine impurity assessment Interdepartmental Coordination

Work Mode

Work from Office

Job Type

Full Time

Job Description

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

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Reqd Regulatory Affairs - Sr Officer/Exe- Pharma API Business