Job Description

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Senior Regulatory Manager

Category: Regulatory

Location:

Bangalore, Karnataka, IN

Are you a skilled and experienced people leader looking for new challenges in a highly innovative and dynamic environment? Are you motivated by cross-functional collaboration and taking responsibility? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as you can look forward to an exciting opportunity working with diverse global stakeholders in RA Labelling as \xe2\x80\x9cSenior Manager\xe2\x80\x9d with us. "Apply now" - At Novo Nordisk, we assure you will experience the best.

About the Department

Global Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub with a strong team of highly skilled regulatory professionals bringing regulatory and scientific excellence. We are committed to secure fast, high-quality approval of new drugs and devices and to expand lifecycle of existing products. The team delivers full strategic and operational support across the value chain and work very closely with our colleagues in RAHQ, Denmark (DK) and our affiliates all over the world. RA Labelling in GRA is responsible for design, development, and execution of secondary packaging material for all Novo Nordisk products worldwide to improve lives of people with diabetes and other serious chronic diseases. Here you have the unique opportunity to join a diverse and high performing RA Labelling area comprising of approximately 90 experienced colleagues based out of Denmark & India.

The Position

The responsibilities for this role will include management of RA labelling designers\' team in accordance with NN way by achieving strategic and operational objectives. You will report directly to the VP of GRA Labelling and become core member of RA Labelling Leadership Team covering both BLR and DK.

• Responsible for planning and coordination of designers\' team in Labelling

• Novo Nordisk packaging material templates to be used for worldwide launches and updates
• Test jobs to the packaging lines on development projects and LCM products
• Timely mock-ups for submissions, question answer phase and approvals according to Health Authorities\' requirements
• Pictures to new launches of new products and LCM products
• Graphic solutions for Novo Nordisk packaging projects/products ensuring that the jobs are delivered timely for worldwide submissions and updates
• Launch readiness - Ensure timely availability of graphic templates to be used on a worldwide basis for launches and updates
• Participate in or lead labelling related projects to ensure compliant, efficient, flexible and innovative processes - ensuring constant audit readiness and reduced lead resulting in continuously optimised quality and timelines of Novo Nordisk packaging material related processes
• Ensure constant inspection (from regulatory Health Authorities) readiness by preparing and participating in GMP audits and by continuously suggesting, evaluating and implementing new preventive actions in collaboration with QA
• Responsible for communicating better practices regarding regulatory procedures, guidelines and other regulatory matters of relevance for the defined area

We are looking for a leader who is enthusiastic and engaged, delivers high-quality results and possesses a can-do attitude. Most importantly, you are proactive, enjoy working under tight deadlines and always strive to find solutions to challenges. You always look for ways to improve the processes and ways of working, adaptive, have well-structured approach to tasks and capability of maintaining overview when under pressure. In addition to the above, you perform your job by using excellent collaboration skills, a sense of humour and enjoys working across geographies & cultures.

Qualifications

• Graduate/Postgraduate/comparable degree in labelling/packaging/design/product supply or relevant area.

• 7 years+ of experience into labelling processes with at least 3 years in a managerial/people management role.
• Ability to successfully manage multiple projects, team and prioritize accordingly.
• Global regulatory experience preferably including experience with EMA/European agencies and US FDA.
• Thorough understanding of graphical labelling processes, supply chain, data and document management systems.
• Strong communication skills in disagreements based on valid arguments and facts.

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

If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.

Deadline

Apply on or before: 5th April 2023

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.

Novo Nordisk