Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Regulatory Professional I- CMC Diabetes
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.
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 preparation of Regulatory file followed by Publishing and Distribution of Dossier.
• 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.
• 5-7 years of experience within Regulatory affairs with Graduate /
• Postgraduate degree in Life-Science / Chemistry / Pharmacy / Medicine.
• 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.
• 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.
Qualification : MSc, M Pharm
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : CMC Diabetes
End Date : 25th February, 2023
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