Are you an experienced EU Regulatory Affairs professional looking to advance your career with an internationally focused pharmaceutical organization? This could be your next big opportunity.
Healthnova Pharma Kft is expanding its Regulatory Affairs team and is hiring for the position of:
🔹 Regulatory Affairs Executive / Regulatory Affairs Manager – Europe
📍 Location: Mumbai
🏢 Department: Regulatory Affairs
📑 Reporting to: Head of Regulatory Affairs / Managing Director / Regional RA Head
This role offers hands-on exposure across the complete EU regulatory lifecycle, from new marketing authorizations to post-approval maintenance, while working closely with global partners and EU authorities.
🏢 About Healthnova Pharma
Healthnova Pharma is a growing pharmaceutical organization with a strong footprint in European regulatory markets. The company focuses on high-quality, compliant medicinal products, collaborating closely with EU CMOs, MAHs, and regulatory authorities to meet evolving EU legislation.
Joining Healthnova means working in a globally aligned regulatory environment, where your expertise directly contributes to international product approvals and lifecycle management.
🎯 Role Purpose
To manage and support EU regulatory activities for medicinal products throughout their lifecycle, including:
- New registrations
- Variations
- Renewals
- Ongoing EU compliance
🧩 Key Responsibilities
📝 EU Regulatory Strategy & Submissions
- Develop and execute EU regulatory strategies for new MA applications
- Prepare, review, and submit EU dossiers
- Support DCP, MRP, and National procedures
🔄 Regulatory Lifecycle Management
- Maintain approved dossiers post-approval
- Manage regulatory changes and updates
- Ensure inspection-ready documentation
🏭 CMO & Partner Coordination
- Coordinate with EU Contract Manufacturing Organizations
- Handle Module 3 (CMC) updates
- Review quality agreements for regulatory impact
✅ Variations, Renewals & Compliance
- Classify and manage variations as per EU Variations Regulation
- Prepare and submit:
- Variations
- Renewals
- Regulatory notifications
- Track timelines and authority commitments
📞 Regulatory Communication
- Act as point of contact with EU authorities
- Manage deficiency letters and responses
- Support inspections with QA teams
🤝 Cross-Functional Collaboration
- Work closely with QA, Manufacturing, and Supply Chain
- Ensure compliance during:
- Manufacturing changes
- Artwork & labeling updates
- Site or supply-chain changes
📊 Regulatory Intelligence & Business Support
- Monitor EU guideline and legislation updates
- Provide regulatory input for:
- In-licensing / out-licensing
- Business development activities
🎓 Qualifications
- Bachelor’s or Master’s degree in:
- Pharmacy (preferred)
- Pharmaceutical Sciences
- Life Sciences
- Chemistry
🧪 Experience Requirements
- Regulatory Affairs Executive: 2–5 years (EU RA)
- Regulatory Affairs Manager: 6–10+ years (EU RA)
Mandatory experience in:
- EU marketing authorization submissions
- EU regulatory lifecycle management
- CMO-based manufacturing regulatory support
🧠 Key Skills
- Strong knowledge of EU pharmaceutical legislation
- Experience with eCTD / NeeS
- Expertise in DCP, MRP, National procedures
- Solid understanding of:
- Module 3 (CMC)
- Change control & regulatory impact assessment
- EU Variations Regulation
- Excellent written & spoken English
- Strong coordination and project management skills
📬 How to Apply
Interested candidates can apply via:
📧 Email: nita@healthnovapharma.in
💬 Direct message (if applicable)
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🚀 Why Consider This Role?
- Direct exposure to European regulatory markets
- End-to-end involvement in EU product lifecycle
- Work with international CMOs and authorities
- Strong growth potential in a high-demand regulatory domain
If EU Regulatory Affairs is your strength and you’re ready for your next professional challenge, this role at Healthnova Pharma could be the perfect fit 🌟
