Regulatory Affairs Senior Manager
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Key skills for this role
About the Role
Viatris seeks a Regulatory Affairs Senior Manager to lead and execute regulatory strategies for the KSA market. The role involves managing a team, ensuring compliance with local regulations, and liaising with global and local stakeholders.
Key Skills for This Role
Responsibilities
- Lead, manage, and execute regulatory strategies for KSA
- Provide oversight for the country team and develop regulatory plans
- Ensure regulatory documentation meets requirements
- Manage direct reports and their performance
- Liaise with global and local stakeholders
- Prepare and review regulatory strategies and plans
Requirements
- Extensive experience in regulatory affairs within the pharmaceutical industry
- Knowledge of KSA regulatory requirements
- Leadership and team management skills
- Strong communication and collaboration skills
Full Job Posting
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.
Position Responsibilities
- Direct line management of Viatris RA team as directed.
- Apply regulatory expertise for assigned country to enable preparation of high quality documentation.
- Ensure development of KSA Market Regulatory Team and maintain knowledge base of country requirements.
- Build in country relationship with stakeholders/partners.
- Manage the performance of direct reports to achieve agreed objectives.
- Provide input to the regulatory strategy for the development of products.
- Implement team spirit/activities in alignment with Viatris culture and values.
- Provide input and liaise with Global Regulatory, Vertical Regulatory Teams, etc.
- Ensure appropriate regulatory systems and database are updated.
- Ensure a submission planning and forecasting tool is utilized.
- Facilitate and support all product lifecycle regulatory work.
- Ensure and oversee the preparation of regulatory strategies and plans.
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.
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