Looking to build your career in Regulatory Affairs and Pharmacovigilance report writing? Here’s an exciting remote opportunity with Mitocon Biopharma Pvt Ltd for professionals skilled in clinical and non-clinical regulatory documentation.
This role is ideal for candidates with 1–5 years of experience in regulatory writing, pharmacovigilance documentation, and CTD modules (2.4, 2.5, 2.6, 2.7). If you have strong expertise in health hazard report preparation and regulatory compliance, this is a high-impact role in a growing life sciences environment.
🔍 Job Overview
- Role: Regulatory Affairs & PV Report Writing Specialist
- Company: Mitocon Biopharma Pvt Ltd
- Work Mode: Remote
- Experience: 1–5 Years
- Industry: Regulatory Affairs, Pharmacovigilance, Medical Writing
🧾 Key Responsibilities
- Prepare Health Hazardous Reports for Regulatory Affairs and Pharmacovigilance
- Draft CTD Modules 2.4 & 2.5 (Clinical) and 2.6 & 2.7 (Non-Clinical)
- Perform regulatory report writing and scientific documentation
- Ensure compliance with global regulatory guidelines (ICH, GCP, PV standards)
- Maintain high-quality clinical and non-clinical report structures
- Collaborate with cross-functional teams for data accuracy and submission readiness
🎓 Qualifications & Requirements
- Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field
- 1–5 years experience in Regulatory Affairs / Pharmacovigilance
- Strong expertise in clinical & non-clinical module writing (CTD)
- Experience in health hazard report drafting
- Excellent scientific writing and documentation skills
- Good communication and stakeholder coordination abilities
💼 Key Skills
- Regulatory Affairs report writing
- Pharmacovigilance documentation
- CTD Modules 2.4, 2.5, 2.6, 2.7
- Clinical regulatory writing jobs remote
- Non-clinical regulatory reports
- Health hazard report analyst
- Medical writing pharmacovigilance
🌟 Benefits
- 🌍 100% Remote Work Flexibility
- 📈 Exposure to global regulatory submissions & PV processes
- 🧠 Opportunity to strengthen medical writing & CTD expertise
- 🚀 Work in a fast-growing biopharma environment
- 🤝 Collaborative and learning-driven team culture
📩 Application Process
Interested candidates can apply directly:
- 📧 Email: sarvani.g@mitoconbiopharma.com
- 📱 WhatsApp: 80194 93434 (Don’t call on weekends)
- 👤 Contact Person: Sarvani (Sr. HR)
👉 Use subject line: Application – Regulatory Affairs & PV Report Writing Specialist