Job Description
Position Sr. Executive – Regulatory & Scientific Affairs Qualification
• M.
Pharm (Pharmacology)

Location:
Vadodara Experience
• 2–3 years of relevant experience in Regulatory Affairs, Scientific Writing, Clinical Research, Pharmacovigilance, Medical Writing, or related pharmaceutical domains. 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:
• European Medicines Agency (EMA)
• United States Food and Drug Administration (US FDA)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• Health Canada
• Therapeutic Goods Administration (TGA)
• Support pre-submission planning, regulatory intelligence activities, and product lifecycle management. Required Skills and Competencies
• Strong literature searching and scientific data interpretation skills.
• Understanding of pharmaceutical development, clinical research, and regulatory requirements.
• Knowledge of toxicity studies, BA/BE studies, and clinical trial methodologies.
• Scientific and regulatory writing skills with attention to detail.
• Ability to critically analyze scientific publications and regulatory guidance documents.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Effective verbal and written communication skills.
• Ability to manage multiple assignments and work within timelines.
• Solid organizational, analytical, and problem-solving abilities.
• Self-motivated, proactive, and capable of working independently as well as within cross-functional teams. Preferred Skills
• Familiarity with CTD/eCTD dossier structure.
• Experience with scientific databases and regulatory portals.
• Exposure to medical writing, clinical evaluation reports, or regulatory submissions.
• Knowledge of ICH, EMA, US FDA, Health Canada, and other international regulatory guidelines. Key Attributes
• Scientific curiosity and attention to detail.
• Strong analytical mindset.
• Commitment to quality and regulatory compliance.
• Ability to learn quickly and adapt to evolving regulatory requirements.
• Collaborative team player with a professional approach.

📌 Executive - Regultory Affairs (Pharmacology) (Vadodara)
🏢 Novumgen
📍 Vadodara