Assistant Manager/Deputy Manager - Formulation Analytical - Peptides Eugia Pharma Specialities

5.0 - 9.0 years

7 - 11 Lacs

Hyderabad

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Job Description : Experience in operation and calibration of (HRMS/qTOF). Experience on Intact Mass Analysis, peptide Mapping, Impurity profiling, unknown impurity structure identification, sequencing of Peptides, biosimilars and small molecules. Independent Data analysis of characterization experiments. Experience in impurity profiling of GLP1 analog peptide API and formulation products. Preparation of summary reports, SOPs, Protocols and Reports Transportation & Canteen Facilities Available

Posted 18 hours ago

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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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