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Job Summary
The Executive – Regulatory & Scientific Affairs will support scientific, clinical, and regulatory activities associated with pharmaceutical product development and lifecycle management. The role involves conducting comprehensive literature reviews, preparing clinical and non-clinical regulatory documents, supporting regulatory submissions, and contributing to scientific evaluations in accordance with global regulatory requirements.

Key Responsibilities
Scientific and Literature Research
Conduct comprehensive literature searches using scientific databases such as PubMed, Embase, Cochrane Library, and regulatory agency databases.
Perform secondary research to gather scientific, clinical, toxicological, and regulatory information from journals, publications, public databases, and health authority resources.
Evaluate and summarize scientific evidence to support product development and regulatory submissions.
Regulatory Writing and Documentation
Assist in the preparation and review of Clinical Overviews, Clinical Summaries, Non-clinical Overviews,



and Non-clinical Summaries (CTD Modules 2.4, 2.5, 2.6, and 2.7).
Support the development of scientific justifications, gap analyses, benefit-risk assessments, and regulatory briefing documents.
Contribute to preparation of dossiers and responses for submissions to global regulatory authorities.

Clinical and Non-Clinical Evaluation
Review and interpret published clinical and non-clinical data.
Analyze toxicity studies, pharmacology studies, pharmacokinetic data, bioequivalence studies, and clinical trial reports.
Support scientific assessment of efficacy, safety, and benefit-risk profiles of pharmaceutical products

Regulatory Affairs Support
Assist in evaluating regulatory pathways and submission strategies for pharmaceutical products.
Monitor and interpret updates from major regulatory agencies, including:

o European Medicines Agency (EMA)
o United States Food and Drug Administration (US

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📌 Sr Executive – Regulatory Mumbai
🏢 Novumgen
📍 Mumbai