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/