Regulatory Professional II

Role Overview Novo Nordisk Global Business Services is looking for a Regulatory Professional II to join their Regulatory Affairs team in Bengaluru. In this role, you will be responsible for ensuring timely and compliant submissions to Health Authorities across the globe while supporting Life Cycle Management and CMC regulatory activities across both regulated and emerging markets. This is an excellent opportunity for a seasoned regulatory professional to contribute to a purpose-driven organisation dedicated to defeating serious chronic diseases. Key Responsibilities - Develop and maintain Regulatory Submission Plans by applying regulatory intelligence and contributing to regulatory strategy formulation - Handle submission of regulatory files, Change Requests, Deviations, RSI and Health Authority queries, Annual Reports, and maintenance of global marketing authorisations - Support NDA roll-outs, product renewals, and Post Approval Changes across regulated and emerging markets - Work with Veeva Vault (Submissions and Registrations) to ensure compliant and efficient regulatory operations - Collaborate with global and affiliate teams across multiple time zones to ensure minimum time-to-market for products - Manage stakeholder relationships effectively through appropriate communication strategies Required Qualifications - Graduate or Postgraduate degree in Life Sciences, Chemistry, Pharmacy, Medicine, or Biotechnology Engineering - Minimum 6 years of experience in Regulatory Affairs with strong RA-CMC knowledge - Strong understanding of end-to-end regulatory processes, Life Cycle Management, and the pharma or biotech value chain - Exposure to regulatory submissions across regulated and emerging markets; experience with China and Japan markets is preferred - Excellent project management, negotiation, and stakeholder engagement skills - Strong written and spoken English communication skills with high cultural sensitivity Why Join Us At Novo Nordisk, you will be part of a global healthcare legacy spanning over 100 years, with unparalleled opportunities for professional growth and development. Join a team that values diverse thinking, shared purpose, and a commitment to creating lasting impact in the lives of millions of patients worldwide.

- Degree in Life Sciences, Chemistry, Pharmacy, Medicine, or Biotechnology Engineering - Minimum 6 years of experience in Regulatory Affairs - Strong RA-CMC knowledge and understanding of Life Cycle Management - Experience with Veeva Vault Submissions and Registrations - Regulatory experience in both regulated and emerging markets - Familiarity with China and Japan regulatory environments preferred - Excellent project management and negotiation skills - Strong written and spoken English communication skills - Ability to manage multiple priorities and work across cultures and time zones

- Opportunity to work with a globally renowned pharmaceutical organisation - Learning and development opportunities across a global network - Inclusive and diverse work culture - Competitive benefits aligned to career stage and life stage - Work on impactful projects that reach millions of patients worldwide