Novumgen is hiring for the position of Executive – Regulatory & Scientific Affairs in Vadodara. The role focuses on scientific, clinical, and regulatory activities related to pharmaceutical product development and lifecycle management, including literature research, regulatory documentation, scientific evaluation, and regulatory submissions.
Job Details
| Details | Information |
|---|---|
| Company | Novumgen |
| Position | Sr. Executive – Regulatory & Scientific Affairs |
| Qualification | M.Pharm (Pharmacology) |
| Location | Vadodara |
| Experience | 2–5 years |
| Relevant Experience | Regulatory Affairs, Scientific Writing, Clinical Research, Pharmacovigilance, Medical Writing, or related pharmaceutical domains |
| Openings | 1 |
Position: Executive – Regulatory & Scientific Affairs
The role will support scientific, clinical, and regulatory activities associated with pharmaceutical product development and lifecycle management. Responsibilities include literature reviews, regulatory writing, scientific evaluations, regulatory submissions, and regulatory intelligence.
Key Responsibilities
Scientific and Literature Research
- Conduct literature searches using PubMed, Embase, Cochrane Library, and regulatory agency databases.
- Perform secondary research covering scientific, clinical, toxicological, and regulatory information.
- Evaluate and summarize scientific evidence for product development and regulatory submissions.
Regulatory Writing and Documentation
- Assist with Clinical Overviews, Clinical Summaries, Non-clinical Overviews, and Non-clinical Summaries for CTD Modules 2.4, 2.5, 2.6, and 2.7.
- Support scientific justifications, gap analyses, benefit-risk assessments, and regulatory briefing documents.
- Contribute to 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.
- 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)
- Support pre-submission planning, regulatory intelligence, and product lifecycle management.
Eligibility / Qualifications
- M.Pharm (Pharmacology)
- 2–5 years of experience
- Relevant experience in Regulatory Affairs, Scientific Writing, Clinical Research, Pharmacovigilance, Medical Writing, or related pharmaceutical domains.
Required Skills
- Literature searching and scientific data interpretation
- Pharmaceutical development and regulatory requirements
- Clinical research knowledge
- Understanding of toxicity studies and BA/BE studies
- Knowledge of clinical trial methodologies
- Scientific and regulatory writing
- Critical analysis of scientific publications and regulatory guidance
- Microsoft Word, Excel, and PowerPoint
- Verbal and written communication
- Analytical and problem-solving skills
- Organizational and time-management abilities
- Ability to manage multiple assignments and work independently and 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
- Attention to detail
- Strong analytical mindset
- Commitment to quality and regulatory compliance
- Ability to learn and adapt to evolving regulatory requirements
- Collaborative and professional approach
Application Details
Interested candidates can send their resume to: