Senior Regulatory Professional
2 days ago
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 Senior Regulatory Professional” 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 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)
Participate in several cross-functional forum representing RA CMC to provide strategic RA input.
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
10-12 years of experience within Regulatory affairs with Graduate /
Postgraduate degree in Life-Science/Chemistry/ Pharmacy/ Medicine/ Biotechnology/ Chemical Engineering.
Experience of working both in Global & Affiliate environment will be preferred.
Good understanding of end-to-end Regulatory Processes and Life Cycle Management.
Strong experience working with HA either through negotiation or preparation of responses to queries.
Bold and strong personality with proven negotiation 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.
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