Regulatory Affairs Executive

Category:  Reg Affairs & Safety Pharmacovigilance
Location: 

Hanoi, Vietnam, VN

 

Are you highly motivated by being able to make a difference in improving patients’ lives? Are you a high-performing executive who is energized by challenges and able to energize people around you? If so, you should continue reading and apply now!


In Novo Nordisk Vietnam, the position of Regulatory Affairs (RA) Executive provides you the opportunity to work in a high-performing team to contribute directly towards the business results while creating value for Diabetes patients.

 

Regulatory Affairs

Primary responsible for Regulatory Affairs - to coordinate the product registration, extension, renewal, variations to health authorities etc.  activities in Novo Nordisk in Vietnam.

 

  • Interact with Vietnam health authorities to obtain new and extension licenses for importing and marketing Novo Nordisk 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 protect company interests, receive and review news and update regulations in Vietnam.
  • Co-ordinate with necessary departments including corporate RA, trademark, patent departments and BASEA RA for regulatory submission, approval and maintenance of product licences 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.
  • Prepare dossiers and submit, follow up to get approval for promotional material where required and drug variation with Drug Advertisement and Information Department at DA Vietnam.
  • Maintain master file and PV tracker by updating regularly with accuracy information.
  • Maintain and update information of Novo Nordisk regulatory systems such as VaultRIMS, LIFT or any other systems as required by HQ/BA.
  • Monitor and update local external requirements within the affiliate.
  • Regulatory compliance to local internal and external requirements in Vietnam.
  • Maintenance of Drug import, drug selling and Medical devices import licenses by ensuring extension and variation approvals within required timelines.
  • Initiation/approval of country-specific labeling and handling of printed packaging materials and ensuring strict compliance to the local labeling requirements. Perform proofreading the country specific packaging to make sure in compliance and accuracy.

 

Qualifications

 

Bachelor’s Degree in Pharmacy, Life Sciences and related disciplines

1-2 years experience in Regulatory

 

 

 

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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