Executive – Regulatory & Scientific Affairs

The Executive – 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 complete pharmaceutical product development lifecycle and international regulatory requirements.

This role is ideal for candidates interested in:
✔ Regulatory Affairs
✔ Scientific Writing
✔ Clinical Research
✔ Drug Development
✔ Dossier Preparation
✔ Benefit-Risk Assessment
✔ Global Regulatory Submissions

🚀 WE’RE HIRING | Executive – Regulatory & Scientific Affairs | Novumgen | Vadodara 🚀

Are you an M.Pharm (Pharmacology) graduate looking to start your career in Regulatory Affairs, Scientific Writing, Clinical Research, and Drug Development? 💊📚

📢 Novumgen is inviting applications for the position of Executive – Regulatory & Scientific Affairs for its Vadodara location.

This is an excellent opportunity for M.Pharm (Pharmacology) Freshers who aspire to build expertise in global regulatory submissions, scientific literature research, dossier preparation, benefit-risk assessment, and pharmaceutical product development.

If you’re passionate about scientific evaluation, regulatory science, clinical and non-clinical research, and international healthcare regulations, this role provides valuable exposure to global regulatory frameworks including ICH, EMA, US FDA, WHO, and Health Canada guidelines.

🏢 Company: Novumgen
🌐 Website: https://www.novumgen.com
🏢 Department: Regulatory & Scientific Affairs
👉 Role: Executive – Regulatory & Scientific Affairs
💼 Experience: Freshers – 3 Years
📍 Location: Vadodara, Gujarat
🏢 Work Mode: Work From Office
🕒 Employment Type: Full-Time
🎓 Qualification: M.Pharm (Pharmacology)
📌 Eligible  Candidates: Freshers Preferred
📌 Specialization: Pharmacology Only

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🔧 Key Responsibilities
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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

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🛠 Required Skills & Qualifications
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✅ M.Pharm in Pharmacology
✅ Freshers are strongly encouraged to apply
✅ Candidates with up to 3 years of experience may also be considered

📌 Important Note:
Only candidates with Pharmacology specialization are eligible for this position.

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📚 Required Knowledge Areas
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Applicants should possess a 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

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🎯 Soft Skills
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✔ Strong Communication Skills
✔ Analytical Thinking
✔ Critical Reasoning
✔ Attention to Detail
✔ Adaptability
✔ Time Management
✔ Team Collaboration

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🎯 What We’re Looking For
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✔ Passion for Regulatory Affairs and Scientific Writing
✔ Interest in Clinical and Non-Clinical Research Evaluation
✔ Strong research and analytical mindset
✔ Ability to interpret scientific data effectively
✔ Commitment to quality, compliance, and accuracy
✔ Willingness to learn international regulatory frameworks
✔ Eagerness to build a long-term career in pharmaceutical regulatory affairs

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🌟 Career Growth Opportunities
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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

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🌟 Why Join Novumgen?
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✨ 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

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📩 Apply Now
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📧 Email: aesha.kandoi@novumgen.com

📌 Email Subject Line:
Pharmabharat Application for Executive – Regulatory & Scientific Affairs

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⚡ If you’re an M.Pharm (Pharmacology) graduate looking to build a successful career in Regulatory Affairs, Scientific Writing, and Global Drug Development, Novumgen offers an excellent platform to learn, grow, and make an impact in the pharmaceutical industry.