 Job Title: Regulatory Coordinator
Job ID: REQ-10022239
Location: India
Summary
Join our team as a Regulatory Coordinator, where you will play a pivotal role in the development and submission of product registrations, progress reports, supplements, amendments, and periodic experience reports. Your contributions will support our mission to ensure compliance with local pharmaceutical regulations and standards.
About the Role
In this role, you will be accountable for:
- Product Registration: Achieving optimal product registration with commercially attractive labeling as per the registration plan.
- License Maintenance: Securing and maintaining product licenses concerning CMC/CDS and safety updates in line with local regulations and company strategies.
- Compliance Oversight: Ensuring adherence to NP4, KRPIA codes of conduct, and relevant laws for CPO activities, including DRAGON updates, RMPs, and drug safety reporting.
- Stakeholder Relations: Fostering and maintaining positive relationships with internal and external stakeholders.
- Adverse Event Reporting: Timely reporting of technical complaints and adverse events related to Novartis products within 24 hours of receipt.
- Marketing Sample Distribution: Managing distribution of marketing samples where applicable.
Key Performance Indicators
- Positive project and stakeholder feedback.
- Timely product license updates in terms of CMC.
- Adherence to Novartis policies and guidelines.
Minimum Requirements
Work Experience:
- Functional breadth across regulatory roles.
- Cross-cultural experience.
- Strong operations management and execution skills.
- Experience in project management.
Skills:
- Excellent analytical skills.
- Knowledge of clinical trials.
- Strong collaboration and teamwork abilities.
- Detail-oriented mindset.
- Background in life sciences.
- Proficient in project planning.
- Thorough understanding of regulatory compliance.
Languages:
- Proficient in English (written and spoken).
Why Join Us?
At Novartis, we believe in the power of diversity and the importance of bringing together unique perspectives. If you are passionate about regulatory affairs and eager to contribute to life-changing innovations, we would love to hear from you!
