Regulatory Affairs Senior Manager
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Key skills for this role
About the Role
Viatris is seeking a Regulatory Affairs Senior Manager to lead and manage regulatory activities for the KSA market. You will develop regulatory strategies, oversee submissions, manage a team, and liaise with stakeholders.
Key Skills for This Role
Responsibilities
- Lead, manage, execute and provide strategic direction to KSA regulatory affairs
- Provide oversight for KSA country team for Viatris portfolio and strategic initiatives to develop and execute regulatory strategies
- Ensure regulatory input is communicated to regional and local Commercial, Supply Chain and Quality teams
- Ensure and supervise that regulatory documentation meets relevant regulatory requirements
- Apply knowledge and best interpretation of regulatory requirements to enable efficient registration of medicinal products
- Direct line management of Viatris RA team as directed
- Build in country relationship with stakeholders/partners and assist team members
- Manage performance of direct reports to achieve agreed objectives and identify training needs
- Provide input to regulatory strategy for product development in line with business objectives
- Facilitate and support all product lifecycle regulatory work
Requirements
- Bachelor’s degree or equivalent in Chemistry, Pharmacy, or a related life sciences
- Saudi National
- Licensed from SCFHS (Saudi Commission for Health Specialties)
- Minimum 10 years of experience in regulatory affairs, preferably in human medicines
- 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
- Knowledge of drug development, regulations and guidelines
- Strong leadership and management qualities, including excellent communication, negotiation, and interpersonal 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.
- To ensure regulatory input is communicated to the regional and local Commercial, Supply Chain and Quality teams.
- 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 ensure business continuity between vertical regulatory teams, Country Regulatory staff and distributors.
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 maintain knowledge base of country requirements and regulatory environment.
- To build in country relationship with stakeholders/partners and assist team members to do the same.
- 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.
- Implement team spirit/activities in alignment with Viatris’ culture and values.
- 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.
- Facilitating and support all product lifecycle regulatory work.
- Ensure and oversee the preparation of regulatory strategies and plans for assigned countries.
- 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.
Education and Experience
- 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 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.
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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