Opportunity for Regulatory Professional Post @Novo Nordisk

Novo Nordisk is a Danish-based multinational company specializing in the research, development, and production of pharmaceuticals for the treatment of diabetes, haemophilia, growth hormone deficiencies, and hormonal imbalances. The company has a strong reputation in the healthcare industry and is dedicated to improving the lives of people living with these conditions.

The Regulatory Professional I position at Novo Nordisk involves supporting the development and submission of regulatory submissions for new drug applications and post-approval changes in the CMC (Chemical, Manufacturing, and Controls) division, focused on diabetes.

Key responsibilities include:

• Supporting submission planning and the preparation of regulatory files
• Handling change requests and deviations
• Responding to regulatory agencies’ inquiries
• Supporting NDA, renewals, and post-approval changes
• Playing a key role in stakeholder management
• Ensuring appropriate communication with stakeholders

The successful candidate will work with cross-functional teams and regulatory agencies to ensure compliance with regulatory requirements and help bring innovative diabetes treatments to market. Experience with Veeva Vault (Submission & Registrations) is desired. This position offers fast-paced professional development and career opportunities in a multi-disciplinary environment.

The ideal candidate for the Regulatory Professional I position at Novo Nordisk should have:

• 5-7 years of experience in Regulatory Affairs
• A Graduate or Postgraduate degree in Life-Science, Chemistry, Pharmacy, or Medicine
• Experience working in both a global and affiliate environment
• A good understanding of end-to-end regulatory processes and life cycle management
• A bold and confident personality with proven negotiation skills
• The ability to take initiative and manage multiple priorities
• Strong personal drive and the ability to engage with colleagues and peers towards delivering excellent performance and results
• High cultural sensitivity and comfort working with different countries and cultures across multiple time-zones
• Excellent written and spoken communication skills

Additional Information:

Qualification & Location: The Regulatory Professional I position at Novo Nordisk requires an MSc or M Pharm qualification and is located in Bangalore.

Functional Area: The role is in the Pharma/Healthcare/Clinical research industry, within the CMC Diabetes functional area.

End Date: The end date for the position is 25th February, 2023.

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