Uniza Group, a division of Pashupati Group, is inviting applications for the role of Regulatory Affairs Executive (ROW Market). If you’re a B.Pharm or M.Pharm professional with solid experience in CTD/ACTD dossier compilation, this could be your next big career leap in international regulatory affairs.
🌍 The Role of a Regulatory Affairs Executive (ROW Focus)
In today’s global pharmaceutical landscape, regulatory affairs is no longer just documentation — it’s strategic market access.
At Uniza, you’ll play a key role in ensuring products meet regulatory requirements across Rest of World (ROW) markets. This includes managing diverse country-specific guidelines outside the US/EU/Japan regions — making the role intellectually challenging and globally rewarding.
📢 Job Overview
- Designation: Regulatory Affairs Executive
- Qualification: B. Pharm / M. Pharm 🎓
- Experience: Minimum 2+ years in core Regulatory Affairs
- Core Expertise: ACTD, CTD & Country-Specific Dossiers
- Market Focus: ROW (Rest of World) 🌏
✅ Eligibility & Required Skills
1️⃣ Educational Qualification
- B.Pharm or M.Pharm (Regulatory Affairs specialization preferred)
2️⃣ Professional Experience
- Minimum 2 years of hands-on experience in:
- Dossier compilation
- International submissions
- Regulatory documentation management
3️⃣ Technical Expertise Required
You should have strong working knowledge of:
- CTD (Common Technical Document)
- ACTD (ASEAN Common Technical Document)
- Country-specific submission formats
- Lifecycle management & variation filings
- Query response drafting
📝 Key Responsibilities
Your day-to-day responsibilities will include:
- 📂 Dossier Compilation – Collecting data from QA, QC, Production & compiling Modules 1–5.
- ⚖️ Compliance Review – Ensuring submissions align with country-specific regulatory guidelines.
- 📬 Regulatory Query Handling – Drafting technical responses for authority queries.
- 🔄 Lifecycle Management – Handling variations, renewals & post-approval changes.
- 🤝 Cross-functional Coordination – Acting as a bridge between corporate & manufacturing teams.
🌟 Why Choose Uniza (A Division of Pashupati)?
Working under the umbrella of Pashupati Group offers:
- 🌎 Exposure to multi-country regulatory frameworks
- 📈 Strong career growth trajectory
- 🧠 Strategic involvement in international product registrations
- 🏆 Brand credibility in your professional profile
- 🤝 Collaborative corporate work culture
Regulatory Affairs is a profit-enabling department — without approvals, there are no exports. That makes your role both impactful and respected.
📩 How to Apply
Interested candidates should send their updated CV to:
💡 Pro Tip:
Highlight:
- Specific countries/regions handled (e.g., ASEAN, Africa, LATAM)
- Number of dossiers compiled
- Experience in handling deficiency letters or queries
- Exposure to eCTD submissions (if applicable)
📈 The Future of Regulatory Affairs
The pharmaceutical industry is rapidly moving toward:
- eCTD digital submissions
- Regulatory harmonization
- Increased scrutiny in ROW markets
Professionals entering now can advance toward:
- Regulatory Affairs Manager
- International Regulatory Lead
- Director – Global Regulatory Affairs
