Apply Now for CMC Regulatory Professional ll position at Nova Nordisk: Are you passionate about creating efficient processes and driving excellence in a future-ready environment?
If you have an innovative mindset and a track record of delivering outstanding results, we have an exciting opportunity for you as a CMC Regulatory Professional II at Novo Nordisk. Join a dynamic team dedicated to ensuring compliance and patient-centric development of medicines and devices.
With a focus on collaboration and professional growth, this role offers the chance to contribute significantly to our mission of impacting millions of lives worldwide. Apply now and become part of a global leader in healthcare.
Apply Now for CMC Regulatory Professional ll position at Nova Nordisk
| Category | Details |
|---|---|
| Position | CMC Regulatory Professional II |
| Department | RA CMC Diabetes & Obesity |
| Company | Novo Nordisk |
| Role Summary | Responsible for timely submissions to Health Authorities, maintaining CMC parts of regulatory files, and managing Life Cycle Management. |
| Key Responsibilities | – Develop Regulatory strategy – Create and maintain Regulatory Submission Plan – Support submissions, change requests, and deviations – Respond to RSI/HA queries – Annual reporting and maintenance of marketing authorization globally – Support NDA, renewals, and post-approval changes – Use Veeva Vault (Submission & Registrations) – Manage stakeholder relationships |
| Qualifications | – 6+ years in Regulatory Affairs/CMC – Graduate/Postgraduate in Life Sciences, Chemistry, Pharmacy, Medicine, Biotechnology Engineering – Experience in Global & Affiliate environments – Understanding of Regulatory Processes and Life Cycle Management |
| Skills Required | – Strong negotiation and project management – Proactive and self-managed – Excellent communication skills – Cultural sensitivity and ability to work across time zones |
| Working Environment | – Collaborative and inclusive culture – Emphasis on diversity and cultural sensitivity – Opportunities for professional development and career growth |
| Application Deadline | 22nd July 2024 |
| Contact | Apply through Novo Nordisk’s online application tool |
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