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Novartis Hiring for Regulatory Coordinator (Freshers)
Position: Regulatory Coordinator
Organization: Novartis
Location: India
Experience: Freshers
Qualification: B.Pharm, M.Pharm, M.Sc, B.Sc, Pharm.D, Life Sciences
Novartis is a global healthcare leader with a focus on life sciences and pharmaceuticals, committed to improving patient health through innovative treatments. We are currently hiring for the position of Regulatory Coordinator in India, offering fresh graduates the opportunity to contribute to regulatory affairs in a dynamic environment.
Job Details
Job Title:
Regulatory Coordinator
Job ID:
REQ-10022239
Location:
India
Experience:
Freshers are welcome
Qualifications:
- B.Pharm / M.Pharm / M.Sc / B.Sc / Pharm.D / Life Sciences
Job Description
As a Regulatory Coordinator, you will support the regulatory affairs team in ensuring Novartis products comply with local regulations and global standards. This role involves the registration of products, maintaining licenses, and overseeing compliance with pharmaceutical regulations.
Key Responsibilities
- Product Registration: Ensure optimal product registration and commercially attractive labeling in line with the registration plan.
- License Maintenance: Maintain product licenses in compliance with CMC/CDS and safety updates, aligned with local regulations.
- Compliance Management: Ensure adherence to NP4, KRPIA codes of conduct, and relevant laws for CPO activities, including regulatory updates.
- Stakeholder Relations: Build and maintain positive relationships with internal and external stakeholders.
- Adverse Event Reporting: Ensure timely reporting of technical complaints and adverse events related to Novartis products within 24 hours of receipt.
- Marketing Sample Distribution: Manage the distribution of marketing samples, if applicable.
Key Performance Indicators
| Responsibility | Performance Metric |
|---|---|
| Product Registration | Timely and accurate product registrations |
| License Maintenance | CMC updates and license renewals in compliance |
| Compliance Oversight | Adherence to Novartis guidelines and regulatory codes |
| Stakeholder Relations | Positive feedback from project stakeholders |
| Adverse Event Reporting | Timely submission of adverse event reports (within 24h) |
Skills & Qualifications
- Analytical Skills: Strong ability to analyze complex regulatory issues and provide solutions.
- Regulatory Knowledge: Understanding of regulatory compliance, including clinical trial regulations.
- Project Management: Ability to manage multiple regulatory projects with precision and attention to detail.
- Collaboration: Excellent team player with cross-cultural experience.
- Language Skills: Proficient in English (written and spoken).
Why Join Us?
At Novartis, we believe in fostering diversity and collaboration. We encourage freshers to bring their unique perspectives and passion for regulatory affairs. If you are ready to contribute to life-changing innovations and grow your career in a supportive environment, we invite you to apply.
Meta Description:
Freshers wanted! Novartis hiring Regulatory Coordinator. Support regulatory affairs in India. Apply with a life sciences background.