Regulatory & PV Specialist
Regulatory,Pricing, PV & QA Department
Novo Nordisk Gulf Cluster (NN GC)
Are you motivated by the opportunity to be part of a highly engaged team with ambitions to develop NN GC? Do you have what it takes: the right drive, a sharp mind, openness and curiosity to other cultures and an interest in partnering with the business? Along with being innovative, agile, bold and great to be around? Then you may be the person we are looking for!
NN GC is looking for a regulatory and PV specialist – (GC is covering Kuwait, Bahrain, Oman, Qatar and Yemen).
This position is based in Kuwait, our GC HQ. As an regulatory and PV specialist you will be part of a small, but immensely important team. You will be reporting to the Manager of RA,Q and PV.
About the Department
NN GC RA. pricing, PV & QA team’s role is to secure license to operate through fast and robust regulatory and pricing approvals. Ensure compliance with NN PV requirements as well as local PV requirements. Compliance to NN Quality requirements. You are the key to our market access. We are tasked with obtaining and maintaining marketing authorizations in the GC countries Kuwait, Qatar, Bahrain, Oman and Yemen.
As a regulatory and PV specialist; You will prepare and submit new products registration files to the authorities according to registration plan timelines. This will be done as a team effort with help and support from your Manager.
As RA you will be responsible for:
- New registrations, Variations and Renewal files preparation, coordination with agents for files submission and approvals.
- Obtain and maintain marketing authorizations to all Novo Nordisk products.
- Maintain packaging material and labelling up-to-date according to HQ / local authorities’ requests.
- Submission of safety data.
- Approval of promotional materials.
As PV you will be responsible for:
You will be responsible for the Pharmacovigilance (PV) system in Novo Nordisk Gulf cluster, including compliance with the NN PV requirements as well as the local PV requirements in each country, you will prepare and submit the PV files for all products registration to local authorities, monitor and follow up with local authorities to ensure timely fulfilment of PV requirements. In addition to that you will be the contact point with regulatory authorities as a QPPV and for any inspection purposes.
Last but not least you will be responsible for the reconciliation and quality check of adverse events with all stakeholders as applicable.
Qualifications
A bachelor degree in pharmaceutical sciences, Solid interpersonal skills and cross functional collaboration.
Ability to influence and collaborate with internal and external key stakeholders. You master English both orally and verbally.
For external candidates:
- Minimum of one to two years regulatory and pharmacovigilance experience in the pharmaceutical field, experience in local RA & PV requirements in gulf countries is preferable,
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Novo Nordisk urges diversity in hiring and in business. All walks of life are therefore encouraged to apply if they fore fill the qualifications.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
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