Novumgen has announced an exciting career opportunity for fresh pharmacy graduates looking to build a career in Regulatory Affairs, Scientific Writing, Clinical Research, and Drug Development. The company is inviting applications for the position of Executive – Regulatory & Scientific Affairs. Candidates with an M.Pharm in Pharmacology are eligible to apply, and freshers are strongly encouraged to submit their applications.
This opportunity offers exposure to regulatory documentation, scientific literature evaluation, clinical and non-clinical assessments, and global regulatory practices, making it an excellent starting point for candidates interested in the pharmaceutical regulatory domain.
Job Overview
Position: Executive – Regulatory & Scientific Affairs
Company: Novumgen
Department: Regulatory & Scientific Affairs
Qualification: M.Pharm (Pharmacology)
Experience: 0–1 Year
Eligibility: Freshers Preferred
Specialization Required: Pharmacology Only
Application Mode: Email Application
Key Responsibilities
Scientific Literature Research
• Conduct literature searches using scientific databases.
• Review, summarize, and organize scientific information.
• Support evidence-based scientific documentation.
Scientific & Regulatory Writing
• Assist in preparation of CTD modules including sections 2.4, 2.5, 2.6, and 2.7.
• Support scientific reports and regulatory responses.
• Prepare justifications and scientific summaries.
Clinical & Non-Clinical Assessment
• Review clinical and non-clinical data.
• Evaluate pharmacology, toxicology, and BA/BE studies.
• Support assessment of efficacy, safety, PK, and PD data.
Regulatory Affairs Support
• Assist in dossier preparation and compilation.
• Monitor global regulatory updates and requirements.
• Support regulatory documentation activities.
Required Qualifications
Candidates should possess:
• M.Pharm in Pharmacology.
• Strong interest in Regulatory Affairs and Scientific Writing.
• Good understanding of pharmacology and clinical research concepts.
• Freshers and candidates with up to 1 year of experience can apply.
Knowledge & Exposure Preferred
• Pharmacology and Toxicology
• Clinical Research
• BA/BE Studies
• Drug Development Process
• CTD Structure
• Benefit-Risk Assessment
• ICH, EMA, US FDA, Health Canada and WHO Guidelines
• GCP and GLP Awareness
Skills & Competencies
Technical Skills
• Literature searching and data retrieval
• Scientific writing and documentation
• Understanding of clinical and non-clinical study designs
• Interpretation of scientific publications
• MS Office and research tools proficiency
Soft Skills
• Strong communication skills
• Analytical and critical thinking
• Attention to detail
• Quick learning ability
• Time management
• Team collaboration
Salary and Benefits
Based on similar entry-level Regulatory Affairs and Scientific Affairs opportunities in the pharmaceutical industry, the expected salary range may be approximately ₹3.0 LPA to ₹5.0 LPA depending on qualifications, skills, and interview performance.
Benefits may include:
• Professional training and mentorship
• Exposure to global regulatory practices
• Career growth in Regulatory Affairs and Scientific Writing
• Opportunities to work on scientific and regulatory projects
• Learning exposure across pharmaceutical product development lifecycle
Career Growth Opportunities
Selected candidates may gain experience in:
• Global Regulatory Submissions
• Clinical and Non-Clinical Scientific Writing
• Literature-Based Dossier Preparation
• Benefit-Risk Evaluation
• Regulatory Strategy and Intelligence
• Pharmaceutical Product Development
How to Apply
Interested and eligible candidates can apply by sending their updated CV to:
Candidates should ensure that their resume highlights academic qualifications, research exposure, project work, internships, and any relevant scientific or regulatory knowledge.
