1.0 - 5.0 years

6 - 12 Lacs

Hyderabad, Chennai, Bengaluru

Hybrid

Warm Greetings from SP Staffing!! Role: JDE Consultant Experience Required :1 to 8 yrs Work Location :Pune/Chennai/Bangalore/Hyderabad/Gurgaon/Mumbai/Chennai/Kolkata Required Skills, MFG/CSMS/SND/Finance/CNC Interested candidates can send resumes to nandhini.spstaffing@gmail.com

Posted 2 days ago

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Jd Edwards Consultant SP Staffing

1.0 - 5.0 years

6 - 12 Lacs

Mumbai, Pune, Delhi / NCR

Hybrid

Warm Greetings from SP Staffing!! Role:JDE Consultant Experience Required :1 to 8 yrs Work Location :Pune/Chennai/Bangalore/Hyderabad/Gurgaon/Mumbai/Chennai/Kolkata Required Skills, MFG/CSMS/SND/Finance/CNC Interested candidates can send resumes to nandhini.spstaffing@gmail.com

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

3.0 - 5.0 years

3 - 5 Lacs

Vadodara

Work from Office

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

Posted 1 month ago

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