Pharmaceutical professionals seeking careers in Regulatory Affairs, Scientific Writing, Clinical Evaluation, and Regulatory Submissions have an excellent opportunity with NOVUMGEN. The company is currently hiring a Sr. Executive – Regulatory & Scientific Affairs for its Vadodara, Gujarat office.

This regulatory affairs job offers exposure to global pharmaceutical regulations, CTD dossier preparation, scientific literature reviews, clinical and non-clinical evaluations, and interactions with major regulatory agencies including the EMA, US FDA, MHRA, Health Canada, and TGA.

Job Details

Key Responsibilities

Scientific Literature Research

• Conduct literature searches using PubMed, Embase, Cochrane Library, and regulatory databases.
• Perform secondary research on scientific, clinical, toxicological, and regulatory information.
• Evaluate and summarize scientific evidence supporting pharmaceutical product development.
• Support scientific documentation required for global regulatory submissions.

Regulatory Writing & Documentation

• Assist in preparation of Clinical Overviews and Clinical Summaries.
• Support Non-clinical Overviews and Non-clinical Summaries (CTD Modules 2.4, 2.5, 2.6, and 2.7).
• Develop scientific justifications and benefit-risk assessments.
• Prepare regulatory briefing documents and submission dossiers.
• Contribute to responses for global health authority submissions.

Clinical & Non-Clinical Evaluation

• Review published clinical and non-clinical data.
• Analyze toxicity studies and pharmacology reports.
• Evaluate pharmacokinetic and bioequivalence study data.
• Support efficacy and safety assessments of pharmaceutical products.
• Review clinical trial reports and scientific evidence.

Regulatory Affairs Support

• Evaluate regulatory pathways for pharmaceutical products.
• Support global submission strategies.
• Monitor regulatory updates from:
  • 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)
• Assist in product lifecycle management and regulatory intelligence activities.

Required Qualifications

Candidates with the following educational backgrounds may be suitable:

• B.Pharm
• M.Pharm
• Pharm.D
• M.Sc Life Sciences
• M.Sc Biotechnology
• M.Sc Clinical Research
• Other relevant pharmaceutical or life science qualifications

Required Skills

• Strong scientific literature review skills
• Knowledge of pharmaceutical development processes
• Understanding of clinical research methodologies
• Regulatory affairs and scientific writing expertise
• Experience interpreting toxicity and bioequivalence studies
• Strong analytical and critical thinking skills
• Excellent written and verbal communication
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Ability to manage multiple projects within timelines

Preferred Skills

• Familiarity with CTD/eCTD dossier preparation
• Medical writing experience
• Exposure to regulatory submissions
• Understanding of ICH guidelines
• Knowledge of EMA, US FDA, MHRA, Health Canada, and TGA requirements
• Experience using scientific databases and regulatory portals

Why Join NOVUMGEN?

Working with NOVUMGEN provides an opportunity to:

• Gain global regulatory affairs exposure
• Work on international pharmaceutical submissions
• Develop expertise in scientific and regulatory writing
• Collaborate with cross-functional pharmaceutical teams
• Build knowledge of international health authority requirements
• Contribute to product development and lifecycle management

How to Apply

Interested candidates can send their updated CV to:

Email: tisha.thakkar@novumgen.com

Applicants should mention “Sr. Executive – Regulatory & Scientific Affairs” in the email subject line for faster processing.

Application Link