Senior Research Scientist – Medical Research
Location: Pune (LRP), Maharashtra, India
Company: Lupin
Date Posted: February 10, 2026
Employment Type: Full-Time
Industry: Pharmaceutical Research & Clinical Development
Lupin is seeking an experienced Senior Research Scientist – Medical Research to support clinical development programs and global regulatory submissions. This position plays a critical role in clinical study review, regulatory documentation, medical monitoring, safety evaluation, and strategic clinical planning across domestic and international markets including the FDA, EMA, and PMDA.
The ideal candidate will bring strong expertise in clinical research, pharmacology, regulatory science, medical writing, and safety data analysis, along with the ability to mentor teams and guide development strategy.
4 to 6 years of experience in:
Clinical research and development
Medical monitoring
Regulatory documentation and submission support
Safety data evaluation and pharmacovigilance review
Clinical strategy development
Experience in handling global regulatory submissions (FDA, EMA, PMDA) and 505(b)(2) pathways will be considered a strong advantage.
MBBS or equivalent medical degree
Postgraduate qualification in Pharmacology (MD Pharmacology or equivalent)
As a Senior Research Scientist – Medical Research, you will:
Review study-related documents including:
Protocols
Investigator Brochures (IB)
Informed Consent Documents (ICD)
Statistical Analysis Plans (SAPs)
Tables, Listings, and Figures (TLFs)
Medical coding reports
Clinical Study Reports (CSR)
Review mock and final TLFs
Evaluate adverse event (AE) and serious adverse event (SAE) datasets
Prepare regulatory briefing books and submission dossiers
Support responses to regulatory authorities, Ethics Committees (EC), and clinical sites
Contribute to 505(b)(2) application evaluations
Assist in global submissions to FDA, EMA, PMDA, and other regulatory agencies
Assess protocol deviations
Evaluate ongoing safety and efficacy data
Perform SAE assessment and medical review
Provide literature searches to inform clinical and regulatory strategy
Support statistical analysis with relevant medical data
Contribute to clinical trial design aligned with current scientific and regulatory expectations
Mentor team members in therapy area knowledge and protocol training
Guide clinical development strategy
Provide oversight in medical monitoring and biostatistical collaboration
Strong understanding of global clinical development frameworks
Expertise in safety data interpretation and risk-benefit evaluation
Knowledge of regulatory submission standards and documentation
Analytical mindset with attention to scientific detail
Ability to interpret statistical outputs and clinical datasets
Strong communication and cross-functional collaboration skills
Leadership and mentoring capabilities
Contribute to global drug development initiatives
Work on regulatory submissions across major international markets
Be part of a research-driven pharmaceutical organization
Engage in high-impact clinical and medical strategy development
Lupin is committed to providing equal employment opportunities in hiring, compensation, promotion, and professional development. All qualified candidates will be considered in accordance with applicable laws and regulations.
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