Regulatory Professional Ii

**About the department**

International Operations Regulatory Affairs Bangalore in Global Regulatory Affairs Global Business Services (GBS) is a global RA hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product approvals. The team delivers full strategic and operational support on a global scale across value chain on core regulatory processes across NN product portfolio. We provide regulatory expertise and work very closely with our colleagues in IORA in Zurich and regions, RAHQ in Denmark as well as colleagues in our affiliates all over the world. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs truly interesting and challenging to work.

**The Position**
- Ensuring RA system update (Veeva Vault) with product dossier & approval information within the agreed timelines.
- Supporting the development of labelling materials, reviewing, and approving the promotional materials and re-packaging specimens according to the local legislation and standard operating procedures.
- Supporting colleagues in affiliates & working very closely with 3rd party distributers in monitoring the local regulatory environment and ensuring overall regulatory compliance is expected.
- Ability to articulate regulatory signals and good understanding of country specific HA requirements.
- This position requires one to be highly self-motivated, proactive, organised and have excellent stakeholder management & communication skills.

**Experience**
- Post-Graduation or comparable degree in science.
- Above 6 years of experience in pharmaceutical industry in Regulatory Affairs.
- 3+ years working with key stakeholders and decision makers outside India in a cross-functional, international environment.
- Experience of working in an Affiliate environment & shared service model preferred
- Good understanding of E2E regulatory processes. Hands on experience on handling conversations with Indian Health authority preferred.
- Hands on experience in compilation of registration/re-registration dossier in national / eCTD / NeeS / ACTD & standard format. Good understanding of Veeva Vault RA systems
- 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
- Basic project management & excellent written/spoken communication skills

**Working At Novo Nordisk**

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales
- we're all working to move the needle on patient care.

**Contact**

**Deadline**

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.