Regulatory Affairs Executive

2 weeks ago

Hanoi, Hanoi, Vietnam Novo Nordisk Full time
Regulatory Affairs Executive

Category:

Reg Affairs & Safety Pharmacovigilance
Location:Hanoi, Vietnam, VN-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.
  • Coordinate 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 countryspecific 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 12 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. #LI-AMS1

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