Research Scientist: Pharma Research Inhalation
Lupin
hace 33 horas
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Descripción de la vacante
Lupin is seeking a Research Scientist for Pharma Research Inhalation in Pune to lead device-related documentation and regulatory submissions. The role requires strong medical writing, risk assessment and design control experience within the pharmaceutical field, aligning with EU MDR and ISO 13485 standards.
Expect to draft technical files and GSPR, collaborate with vendors, and contribute to risk assessments, design verification, and biological evaluation.
Formación
- 8-10 years of experience in the Pharmaceutical Industry.
- Experience drafting SOPs, technical protocols and reports.
- Experience with drug-device combination products and design control documentation.
Responsabilidades
- Medical writing of the device related documentation.
- Experience with EU MDR Regulation.
- Experience drafting technical documentation for US and EU (Technical files, GSPR, dossier sections).
- Experience with drafting SOPs, technical protocols and reports.
- Experience working with and managing relevant vendors.
Conocimientos
Medical writing
EU MDR Regulation
Documentation drafting
Risk Assessments
Design Verification
Biological Evaluation
Educación
Graduation in Science or Engineering
Herramientas
ISO 13485 QMS
21 CFR 820
Descripción del empleo
Research Scientist: Pharma Research Inhalation
- Date: Oct 14, 2026
- Location: Pune_RD, MH, IN
- Company: Lupin
- Medical writing of the device related documentation
- Experience with EU MDR Regulation
- Experience drafting technical documentation for both US and EU (Technical files, GSPR, dossier sections)
- Experience with ISO 13485 QMS, 21 CFR 820
- Experience with drafting SOPs, technical protocols and reports
- Experience with writing doc’s for Risk Assessments, Design and Process Verification, Biological Evaluation
- Experience working in the Pharmaceutical Industry
- Experience with drug-device combination products and design control documentation
- Working with and managing relevant vendors
Work Experience
8-10Years
Education
Graduation in Science or Engineering
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