Regulatory Affairs Senior Manager

## Regulatory Affairs Senior Manager Aplikujlocations:
Riyadh-Office time type:
Praca na pełny etatposted on:
Opublikowano dzisiajjob requisition :
R5670365

VIATRIS ARABIA LIMITED "LLC"Viatris to globalna firma medyczna, która jest wyjątkowo pozycjonowana, by zniwelować tradycyjne podziały między lekami generycznymi a markami, łącząc najlepsze z obu, aby bardziej kompleksowo odpowiadać na potrzeby zdrowotne na całym świecie. Z misją umożliwienia ludziom na całym świecie zdrowszego życia na każdym etapie życia, zapewniamy dostęp na dużą skalę, obecnie dostarczając wysokiej jakości leki około miliardowi pacjentów rocznie i dotykając wszystkich momentów życia – od narodzin po koniec życia, od ostrych schorzeń po choroby przewlekłe.
Zostaliśmy uwzględnieni na wielu listachnagród, które pokazują wpływ, jaki wywieramy.  
** POSITION SUMMARY
*** Lead, manage, execute and provide strategic direction to KSA.
* Provide oversight for KSA, the country team for the Viatris portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post approval submissions.
* To ensure regulatory input is communicated to the regional and local Commercial, Supply Chain and Quality teams for promoted and development products and the implementation of special projects.
* To ensure and supervise that regulatory documentation meets relevant regulatory requirements.
* To apply knowledge and best interpretation of regulatory requirements in the assigned countries to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
* To ensure business continuity between vertical regulatory teams, Country Regulatory staff and distributors supporting Regulatory activities for Viatris portfolio.
** POSITION RESPONSIBILITIES
*** Direct line management of Viatris RA team as directed.  Requires hands on execution in market where the role is located.
* Apply regulatory expertise for assigned country to enable preparation of high quality documentation and assure compliance with departmental procedures.
* Ensure development of KSA Market Regulatory Team and and maintain knowledge base of country requirements and regulatory environment.
* To build incountry relationship with stakeholders/partners and assist team members to do the same with local stakeholders/partners and ensure communication/clarity of regulatory strategy and timelines.
* Manage the performance of direct reports to achieve agreed objectives and to identify and address training and development needs.
* Provide input to the regulatory strategy for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans.
* Implement team spirit/activities in alignment with Viatris’ culture and values to help retain/attract talents
* Provide input and liaise with Global Regulatory, Vertical Regulatory Teams, Viatris Global supply, Submissions Management, Market Regulatory Teams, Labeling CoE, Artwork coordinators, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and HA’s requirements are met, ensuring a submission ready dossier. Responsible that the appropriate regulatory systems and database are updated in a timely manner when changes occur.

Ensure a submission planning and forecasting tool is utilized to update timelines.
* Facilitating and support all product lifecycle regulatory work, and liaise with Vertical Regulatory Teams, Submissions Management, Cluster/Market, and any other key stakeholders.
* Ensure and oversee the preparation of regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
* Ensure adequate input to the local/regional Viatris commercial strategic planning process as appropriate.
* Advise, where necessary, with direct reports and Vertical Regulatory teams the receipt, distribution and response to…