Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
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 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.
ORGANIZATIONAL RELATIONSHIPS
Reports to the Head of MENA Regulatory Affairs.
Direct Reports: Country Regulatory Teams
Key stakeholders: Middle East Country and Cluster Commercial Leads, Supply Chain and Quality , Vertical Regulatory Leads.
RESOURCES MANAGED
Financial Accountability
N.A.
N.A.
Supervision
Indicate the typical number of Colleagues managed. Include direct & indirect reports, matrix responsibility and or additional resources (i.e. contingent workers), where applicable. If not applicable, indicate NA.
Approx av 3-5
EDUCATION
Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
MSc, MBA or PhD may be an advantage
Saudi National.
Licensed from SCFHS (Saudi Commission for Health Specialties).
EXPERIENCE
Experience in regulatory affairs, preferably in human medicines - minimum 10 years of experience.
Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
Proven 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.
Demonstrate experience of effective delivery in a complex matrix environment.
Knowledge of Regional and Global Regulatory environment
Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
Knowledge of drug development, regulations and guidelines
Strong leadership and management qualities, including excellent communication, negotiation, and interpersonal skills
Understanding of pharmaceutical industry, clinical trials and pharmacovigilance
Knowledge and understanding of quality systems, processes, audit and inspection
Ability to influence at all levels in the organization
Able to simplify complex ideas and processes
Team player
Growth focused
Analytical thinking
Talent development
Change agile
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.
Based on 3,320 disclosed Healthcare salaries on RoleSuite, the role pays a median of $110K/year, with most offers between $86K and $165K (10th–90th percentile: $65K–$246K).
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