Regulatory Professional

5 days ago

bangalore, India Novo Nordisk AS Full time

Department : RA CMC Diabetes & Obesity

Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “CMC Regulatory Professional II” with us. "Apply now" - At Novo Nordisk, we assure you will experience the best.

About the department

Regulatory Affairs plays an important role in ensuring all Novo Nordisk Medicines and Devices developed with compliance and keeping patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs will be involved throughout phases of product development, NDA and maintenance of LCM activities. Our people in Regulatory Affairs come from diverse academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to reach the markets. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities.

The Position

As Regulatory Professional, the candidate will be responsible for making the timely submissions to the Health Authorities worldwide. The candidate is expected to establish and maintain the CMC part of the core regulatory file. Further responsibilities include Life Cycle Management.

Support submission planning: Apply intelligence and negotiation skills to 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

 6+ years of experience within Regulatory affairs/CMC with Graduate / Postgraduate degree in Life-Science/ Chemistry/ Pharmacy/ Medicine/ Biotechnology engineering. Experience of working both in Global & Affiliate environment . 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.

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