The pharmaceutical and life sciences industry is rapidly evolving, with increasing emphasis on precision, compliance, and high-quality documentation. In this landscape, specialized roles like Regulatory Affairs (RA) and Pharmacovigilance (PV) writing have become indispensable.
A promising opportunity has now opened at Mitocon Biopharma Pvt Ltd for the position of Regulatory Affairs & PV – Report Writing Specialist. This 100% remote role is ideal for professionals with 1–5 years of experience who want to build a niche in regulatory medical writing.
📌 Job Overview
| Feature | Details |
|---|---|
| Organization | Mitocon Biopharma Pvt Ltd |
| Role | Regulatory Affairs & PV – Report Writing Specialist |
| Work Mode | 100% Remote (Work From Home) |
| Experience | 1–5 Years |
| Key Focus | Health Hazardous Reports & CTD Modules |
🧠 Understanding the Role
This position sits at the intersection of science, compliance, and communication. It goes beyond basic writing—you’ll be transforming complex clinical and non-clinical data into structured documents that meet global regulatory standards.
🔍 Key Responsibilities
1. Health Hazardous Report Preparation
You will develop detailed reports assessing potential health risks of pharmaceutical products. These are critical for:
- Internal safety evaluation
- Regulatory submissions
- Post-marketing surveillance
2. CTD Module Expertise
A strong understanding of the Common Technical Document (CTD) is essential.
Clinical Modules:
- 2.4 – Clinical Overview
- 2.5 – Clinical Summary
These require interpreting clinical trial results and presenting a clear case for safety and efficacy.
Non-Clinical Modules:
- 2.6 – Non-clinical Summary
- 2.7 – Non-clinical Overview
These focus on:
- Pharmacology
- Pharmacokinetics
- Toxicology data
3. Regulatory Compliance
You’ll ensure all documentation aligns with international standards such as:
- ICH guidelines
- GVP (Good Pharmacovigilance Practices)
- GCP (Good Clinical Practices)
Accuracy, consistency, and attention to detail are critical here—there’s no room for approximation.
💻 Why Choose a Remote PV/RA Role?
Remote roles in life sciences are becoming increasingly popular—and for good reason:
- 🏡 Work-life flexibility
- 🎯 Deep focus on technical tasks
- 🌍 Access to global projects
- 📈 Opportunity to specialize in medical writing
For professionals early in their careers, this is a great way to build a strong niche skillset.
🎯 Required Skills & Qualifications
To succeed in this role, candidates should have:
- Experience: 1–5 years in Regulatory Affairs or Pharmacovigilance
- Technical Writing Skills: Ability to draft clear, compliant scientific documents
- Knowledge Base: Familiarity with CTD modules and regulatory frameworks
- Communication: Strong written English and structured thinking
- Attention to Detail: Critical for regulatory documentation
✉️ How to Apply
If you meet the criteria and are ready to advance your career:
- 📧 Email: Send your CV to sarvani.g@mitoconbiopharma.com
- 💬 WhatsApp: 80194 93434
- 👩💼 Contact Person: Sarvani (Sr. HR)
- ⚠️ Note: Avoid calling on weekends
⏳ This is an urgent requirement—early applications are encouraged.
🚀 Final Thoughts
As regulatory standards become more stringent worldwide, roles like Regulatory Affairs & PV Report Writing Specialist are gaining strategic importance. This opportunity at Mitocon Biopharma Pvt Ltd offers not just a job, but a pathway into high-demand medical writing and regulatory expertise.
If you’re someone who enjoys analyzing data, structuring information, and working with precision, this could be the perfect next step in your career.
