Upjohn Export B.V. (Saudi Arabia)

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via: 

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and services. 
 

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

The Marketing Associate will 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.

Every day, we rise to the challenge to make a difference and here’s how the RA Senior Manager role will make an impact:

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 talentsProvide 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.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 regulatory queries from target countries, consistent with procedures and including liaison with response team members to ensure that response targets are met.Develop detailed understanding of regulatory guidelines and technical requirements and support maintenance of regulatory requirements database and assist Regulatory Policy with assessing the regulatory environment and identifying relevant trends.Regularly follow up with Market Regulatory Teams and distributors (if applicable) on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. MSc, MBA or PhD may be an advantage 10 years of experience in regulatory affairs within the pharmaceutical industryProven ability to manage complex Regulatory issues and consistently deliver to time, cost and quality standards.Regional Regulatory experience including knowledge of NDA, sNDA, ANDA, MAA submission processes and Product lifecycle management processes.Knowledge of Regional and Global Regulatory environmentTechnically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks. Understanding of drug development, clinical trials and pharmacovigilanceKnowledge and understanding of quality systems, processes, audit and inspectionPrevious experience as a people managerDemonstrate experience of effective delivery in a complex matrix environment.Ability to influence at all levels in the organization

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Why Viatris?

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer.