Executive - Regulatory and Scientific Affairs

Novumgen Limited; Vadodara; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Novumgen Limited in Vadodara is seeking a Sr. Executive Regulatory & Scientific Affairs to support regulatory and scientific activities across product development and lifecycle management.

You will conduct comprehensive literature reviews, prepare regulatory documents, assist in regulatory submissions, and contribute to scientific evaluations ensuring compliance with global regulatory requirements.

Qualifications

• M.Pharm (Pharmacology) is required.
• Strong literature searching and data interpretation skills.
• Knowledge of regulatory writing and documentation practices.
• Familiarity with CTD/eCTD dossier structure is preferred.

Responsibilities

• Conduct literature searches using PubMed, Embase, Cochrane Library, and regulatory databases.
• Prepare and review Clinical/Non-clinical Overviews and Summaries (CTD Modules 2.x).
• Support dossiers and responses for regulatory submissions to global authorities.
• Review published clinical and non-clinical data and assess efficacy, safety, and benefit‑risk.
• Monitor regulatory updates from EMA, FDA, MHRA, Health Canada, and TGA.

Skills

Literature searching

Regulatory writing

Regulatory compliance

Analytical mindset

Cross-functional collaboration

Project management

Independent work

Education

M.Pharm (Pharmacology)

Tools

CTD/eCTD dossier structure

Regulatory portals

Microsoft Office Suite

Job description

Job Description

Position: Sr. Executive Regulatory & Scientific Affairs

Qualification: M.Pharm (Pharmacology)

Location: Vadodara

Experience

• 25 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.
• Strong 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.