Labelling Professional

**Department: Labelling Projects & Planning**

**About the Department**

Global Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub consisting of a strong team of high calibre regulatory professionals. The objective of the team is to offer core Regulatory Affairs (RA) competencies enabling NovoNordisk (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 RAHQ, Denmark (DK) as well as colleagues in our affiliates all over the world.

**The Position**:
As a Labelling professional, you will ensure planning and coordination of packaging material for all products for markets worldwide in collaboration with partners in RA, Affiliate, Product Supply and Marketing. Be involved in planning and ensuring of creation and maintenance of printed packaging materials (8-numbers) by coordinating with different stakeholders across NN business areas. Also, ensure coordination of launches for new printed packaging material and ensure review of 7 item numbers. You are entrusted to fulfil the following responsibilities:

- Assess labelling request for new/updated packaging material and collaborate with affiliates and other relevant stakeholders to align expectations.
- Ensure planning of labelling request in collaboration with RA and Product Supply and participate in project groups for small
- and medium-scale projects.
- Plan medium-complexity labelling launches using relevant planning tools and systems together with relevant stakeholders from RA, Affiliates and Product Supply
- Ensure tracking and progress of medium-complexity labelling launches using relevant planning tools and systems.

**Experience**:

- Bachelor/Masters degree in science/pharmacy/medicine or equivalent.
- 5-8 years relevant experience or equivalent knowledge through relevant practical experience, both within some of the below qualifiers.
- Regulatory science & requirements - EU, US, China, Japan.
- Late-stage drug development, Life Cycle Management, Label development, Health Authority interactions, Device development, Regulatory Intelligence.
- Other Key qualifires are Project management, Business management understanding, R&D Value Chain and pharma understanding, Digital Health, Competitive intelligence, Pharmacovigilance, Non-clinical, Clinical Pharmacology, Market Access, Real World Evidence.
- Fluent in written and spoken English.
- Show ability and willingness to quickly adjust to new situations in a continuously developing environment.
- Act with boldness in decision making based on risk evaluation.
- Committed, persistent and accountable.
- Goal-oriented and act customer oriented.
- Show ability to manage variable workload.

**Working At Novo Nordisk**

We are a proud life-science company, and life is our reason to exist. We’re in-spired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific re-search, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

**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.