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 II
About the department
Global Regulatory Affairs is an exciting area involved across the full value chain. We are responsible for global regulatory strategies to obtain and maintain regulatory licenses for current and future products, responsive to the worldwide business needs of Novo Nordisk. In this role, you will have the unique opportunity to be part of a strategically crucial business transformation program across multiple processes and geographies and take active part in shaping the way Regulatory Affairs (RA) will work in the future. You will join the RA Business Transformation department that plays a key role to support and enable this transformation. The department consists of 20 regulatory professionals, Specialists and Business Analysts located in Denmark and India. The department is committed towards innovation on the way we work : We embrace a flexible workplace, with a blend of in-office and remote work.
As Regulatory Professional the responsibilities include continuous optimisation of the submission process and system, triggered by evolving business needs and the 3 yearly system releases from Veeva. The key purpose of the role is to impact processes and solutions while ensuring business value via smooth adoption in the organisation.
Further it requires, engaging with stakeholders and external vendors, providing technical guidance and regulatory input to ensure fit for purpose processes and solutions. This role also requires ensuring alignment with external regulatory requirements. The candidate will play a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders (both internal and external).
• Graduate/Postgraduate in science/pharmacy or equivalent discipline with 3-6 years of regulatory experience from the pharmaceutical industry.
• Experience with agile Project Management and the SAFe framework is an advantage.
• Experience with Veeva´s Vault RIM suite is an advantage.
• Self-managed, highly proactive, 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.
• Analytical mind-set, flair for IT and excellent written/spoken communication skills.
Qualification : Graduate / Postgraduate in science /pharmacy
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory
End Date : 30th April, 2023
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