Location: Bangalore, Karnataka, IN
- Support submission planning: Apply intelligence and develop Regulatory strategy. Create and maintain Regulatory Submission Plan including creation/review documents.
- Support submission of Regulatory files, Handling Change Requests & Deviations, response to RSI/ HA query worldwide, Annual Reporting and maintenance of marketing authorization globally.
- Support to NDA, Renewals & Post Approval Changes.
- Hands on experience with Veeva Vault (Submission & Registrations).
The candidate will be playing a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders.
Qualification
- 7-8 years of experience within Regulatory affairs with Graduate /
- Postgraduate degree in Life-Science/ Chemistry/ Pharmacy/ Medicine/ Biotechnology engineering.
- Experience of working both in Global & Affiliate environment will be preferred.
- Good understanding of end-to-end Regulatory Processes and Life Cycle Management.
- Bold and strong personality with proven negotiation skills and excellent project management skills.
- Should be able to convince and put forward the facts confidently.
- Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results.
- High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.
- Excellent written/spoken communication skills.
Apply here: https://careers.novonordisk.com/job/Bangalore-Regulatory-Professional-II-Karn/1025432501/