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Are you highly motivated by being able to make a difference in improving patients’ lives? Are curious about drug development within chronic and rare diseases? Do you want to develop yourself as a Senior Regulatory Affairs and Pharmacovigilance expert in a growing international organization, then this might be the perfect opportunity for you! Join us by applying for the role of Regulatory Affairs (RA) and Pharmacovigilance (PV) Executive based in Hanoi, Vietnam. Apply now!

About the department

Novo Nordisk (NN) is a global healthcare company with 100 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders, rare diseases, and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 60,000 people globally and markets its products in more than 170 countries.

As part of a globally successful pharmaceutical business, Novo Nordisk Vietnam is a high-growth affiliate with an exciting growth trajectory and pipeline in new products and therapy areas in the coming years. We proudly live our purpose of improving the lives of patients within the therapy areas our products treat and put both patients and people firmly in the centre of everything we do.

The position

As a Senior RA and PV Executive, you will be responsible for Regulatory Affairs, coordinating the product registration, extension, renewal, variations to health authorities etc. and other activities as well as acting as a key person in charge of PV in Novo Nordisk Vietnam. This role will report to the Senior RA and PV Manager.

Key responsibilities include but not limited to:

  • Interact with Vietnam Health Authorities (HA) to obtain new and extension licenses for importing and marketing products, conduct technical and commercial discussions with concerned authorities and address queries, review labeling updates, represent company interests during external presentations, influence government decisions in order to ensure compliance to applicable business norms and policies and defend company interests, receive and review news and update regulations in Vietnam.
  • Coordinate with necessary departments including RA, trademark, patent departments and Business Area South East Asia (BASEA) RA for regulatory submission, approval, and maintenance of product licenses in support of Novo Nordisk Vietnam affiliate business needs. 
  • Prepare dossiers for regulatory new/extension registration submission and submit to HA in support of Novo Nordisk Vietnam affiliate business needs. Regulatory review of promotional materials and maintain master file and PV tracker by updating regularly with accurate information.
  • Initiation/approval of country-specific labeling and handling of printed packaging materials and ensuring strict compliance with the local labeling requirements. Perform proofreading of the country-specific packaging to ensure compliance and accuracy.
  • Ensure PV System in the affiliate is maintained and in compliance with Novo Nordisk requirements and external requirements. Also, monitor and report new/changes in PV requirements to Global Safety timely through the established Novo Nordisk system, and ensure implementation of new requirements locally.

Qualifications

  • Minimum bachelor’s degree in Pharmacy, Life Sciences and related disciplines.
  • With 1-3 years of experience in regulatory.
  • Must have knowledge in regulatory regulations.
  • Must have a strong communication, social, and presentation skills.
  • Working experience in multinational company is preferred.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We’re inspired 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 research, 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

Upload your CV to our online career page (click on Apply and follow the instructions).

Internal candidates are requested to inform their line manager when applying. 

Deadline

Until the completion of recruitment. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

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.

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Confirmed 21 hours ago. Posted 16 days ago.

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