Research Scientist: Pharma Research Inhalation

Lupin; Pune District; Presencial; INR 2.000.000 - 3.500.000; Jornada completa

Descripción de la vacante

Lupin in Pune is seeking a Research Scientist for Pharma Research Inhalation. You will lead medical writing of device-related documentation and ensure compliance with EU MDR and US/EU regulatory requirements.

The role requires drafting technical files, GSPR and dossier sections under ISO 13485 QMS and 21 CFR 820, plus SOPs, protocols, and risk assessments. You will collaborate with vendors and contribute to drug-device combination projects.

Formación

• Medical writing of device-related documentation.
• Experience with EU MDR Regulation.
• Experience drafting technical documentation for US and EU (Technical files, GSPR, dossier sections).
• Experience with ISO 13485 QMS and 21 CFR 820.
• Experience drafting SOPs, technical protocols and reports.
• Experience with writing docs 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.

Responsabilidades

• Medical writing of device-related documentation tasks.
• Prepare and manage regulatory documentation for EU/US markets.
• Maintain ISO 13485 QMS compliant procedures and records.
• Draft SOPs, protocols and reports to support development programs.
• Coordinate with vendors and cross-functional teams on documentation deliverables.

Conocimientos

Medical writing

EU MDR

Technical documentation drafting

SOPs & reports drafting

Risk assessments & verification

Regulatory liaison

Vendor management

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

Connect With Us

Follow our social channels to get a
glimpse of life at Lupin