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If you’re aiming to build a strong career in Regulatory Affairs (RA) within manufacturing plants, this opportunity at Icpa Health Products is highly relevant. The company is hiring Regulatory Affairs Officers (Plant RA) for its Ankleshwar facility, focusing on dossier preparation, global regulatory compliance, and ICH guidelines.
This role is ideal for candidates with formulation experience and exposure to international markets like EU, UK, Australia, and Ukraine, making it a valuable step toward global regulatory careers.
📌 Job Overview
- Role: Regulatory Affairs Officer (Plant RA)
- Company: Icpa Health Products
- Location: Ankleshwar (Gujarat)
- Experience: 1–4 years
- Salary: ₹2.5 – ₹4.5 LPA
- Openings: 4
- Employment Type: Full-time, Permanent
- Department: Regulatory Affairs / Compliance
🔑 Key Responsibilities
As a Regulatory Affairs Officer (Plant RA), your responsibilities will include:
- Preparation and submission of dossiers in CTD & ACTD formats
- Ensuring compliance with ICH guidelines and global regulatory standards
- Handling regulatory requirements for EU, UK, Australia, and Ukraine markets
- Managing regulatory documentation and lifecycle maintenance
- Coordinating with internal departments for plant-based regulatory activities
- Maintaining proper document management systems (DMS)
- Supporting audits and inspections related to regulatory compliance
🎓 Qualifications & Eligibility
Educational Requirements:
- B.Pharm (Mandatory)
- M.Pharm (Preferred)
Experience Required:
- 1–4 years in Regulatory Affairs (Plant/Manufacturing RA)
- Experience in formulation-based products (mandatory)
Key Skills:
- CTD / ACTD dossier preparation
- Knowledge of ICH guidelines
- Exposure to EU, UK, Australia regulatory frameworks
- Strong documentation and communication skills
- Regulatory submission lifecycle understanding
💼 Benefits of This Role
- 🌍 Exposure to international regulatory markets
- 🏭 Hands-on experience in plant-based RA operations
- 📈 Career growth in global regulatory affairs domain
- 🧠 Opportunity to work on dossier submissions and compliance strategy
- 🤝 Direct interaction with cross-functional teams (QA, Production, R&D)
📩 How to Apply
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