Looking to start your career in Regulatory Affairs, Scientific Writing, and Drug Development? Novumgen is inviting applications from M.Pharm (Pharmacology) freshers for the position of Executive โ Regulatory & Scientific Affairs. This opportunity offers hands-on exposure to global regulatory submissions, clinical and non-clinical evaluation, scientific literature research, and dossier preparation.
For candidates aspiring to build a career in pharmaceutical regulatory affairs, scientific writing, pharmacovigilance support, and drug development, this fresher opportunity provides valuable industry experience with exposure to international regulatory guidelines including ICH, EMA, US FDA, WHO, and Health Canada.
Job Details
| Particulars | Details |
|---|---|
| Position | Executive โ Regulatory & Scientific Affairs |
| Company | Novumgen |
| Qualification | M.Pharm (Pharmacology) |
| Experience | 0โ1 Year |
| Eligible Candidates | Freshers Preferred |
| Specialization | Pharmacology Only |
| Job Category | Regulatory Affairs & Scientific Affairs |
| Employment Type | Full-Time |
About the Role
The Executive โ Regulatory & Scientific Affairs position focuses on supporting scientific evaluations, regulatory submissions, literature-based dossier development, and benefit-risk assessments. Selected candidates will work closely with regulatory and scientific teams while gaining practical exposure to the pharmaceutical product development lifecycle.
This role is ideal for M.Pharm Pharmacology graduates interested in:
- Regulatory Affairs
- Scientific Writing
- Clinical Research
- Drug Development
- Dossier Preparation
- Benefit-Risk Assessment
- Global Regulatory Submissions
Key Responsibilities
Scientific Literature Research
- Conduct literature searches using scientific databases.
- Review and analyze published scientific literature.
- Summarize and organize scientific data for regulatory purposes.
- Retrieve relevant evidence supporting regulatory submissions.
Scientific & Regulatory Writing
- Assist in preparation of CTD Modules 2, 4, 2.5, 2.6, and 2.7.
- Support scientific reports and regulatory documentation.
- Prepare scientific justifications and regulatory responses.
- Contribute to dossier preparation activities.
Clinical & Non-Clinical Assessment
- Review pharmacology and toxicology studies.
- Evaluate clinical and non-clinical data.
- Analyze BA/BE study reports.
- Support assessment of efficacy, safety, and PK/PD data.
Regulatory Affairs Support
- Assist in dossier compilation and submissions.
- Monitor global regulatory updates.
- Support compliance with international regulatory requirements.
- Contribute to regulatory intelligence activities.
Eligibility Criteria
Educational Qualification
- M.Pharm in Pharmacology
Experience
- Freshers are strongly encouraged to apply.
- Candidates with up to 3 year of experience may also be considered.
Important Note
Only candidates with Pharmacology specialization are eligible for this position.
Required Knowledge Areas
Applicants should possess basic understanding of:
- Pharmacology
- Toxicology
- Clinical Research
- Drug Development Process
- BA/BE Studies
- CTD Structure
- Benefit-Risk Assessment
- GCP (Good Clinical Practice)
- GLP (Good Laboratory Practice)
- ICH Guidelines
- EMA Regulations
- US FDA Regulations
- WHO Regulatory Requirements
- Health Canada Guidelines
Skills Required
Technical Skills
- Scientific literature searching
- Data retrieval and analysis
- Scientific writing
- Regulatory documentation
- Clinical study interpretation
- Non-clinical study evaluation
- MS Office proficiency
- Research database utilization
Soft Skills
- Strong communication skills
- Analytical thinking
- Critical reasoning
- Attention to detail
- Adaptability
- Time management
- Team collaboration
Career Growth Opportunities
Joining Novumgen can provide exposure to:
- Global Regulatory Submissions
- Scientific and Medical Writing
- Clinical Evaluation Reports
- Non-Clinical Assessment Reports
- Literature-Based Dossier Preparation
- Regulatory Intelligence
- Benefit-Risk Evaluation
- Pharmaceutical Product Development Lifecycle
- International Regulatory Strategy
Why Apply for This Role?
- Excellent opportunity for M.Pharm Pharmacology freshers.
- Exposure to international regulatory frameworks.
- Hands-on experience in scientific and regulatory writing.
- Learn dossier preparation and CTD compilation.
- Work on clinical and non-clinical evaluations.
- Develop expertise in drug development and regulatory submissions.
- Build a strong foundation for long-term regulatory affairs careers.
How to Apply
Interested and eligible candidates can apply by sending their updated CV to:
Email: aesha.kandoi@novumgen.com
Candidates should mention “Pharmabharat Application for Executive โ Regulatory & Scientific Affairs” in the email subject line for faster processing.