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Regulatory Professional II
3 months ago
Department: RA CMC Biotech and Rare Disease
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 “Regulatory Professional II” with us. "Apply now" - At Novo Nordisk, we assure you will experience the best.
About the department
RA CMC & Device Bangalore is an integral part of RA CMC & Device and comprised of +60 experienced professionals associated with key regulatory processes covering Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR) and submission of regulatory files, product registrations and life cycle management of our products. We are responsible for driving the RA CMC strategies and submission activities related to various biotech and rare disease, Diabetes & Obesity products and medical devices.
We strive to be the best in the industry, delivering safe and innovative products to the patients by strategic business partnering, proactive collaboration with health authorities and efficient operations.
Our organization is dynamic and there is focus on improving work processes both in relation to implementation of new regulations and thinking “out of the box”, setting bold regulatory strategies enabling us to go above and beyond to the benefit of the business and the patients we serve. We continuously strive for scientific and operational excellence.
Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. Looking forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people.
The Position
As Regulatory Professional II, 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 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.Working At Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us Together, we go further. Together, we’re life changing.
