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 the KSA regulatory team, execute regulatory strategies, and ensure compliance for the Viatris portfolio. Requires 10+ years of regulatory affairs experience in human medicines, a Bachelor's degree in a life science, and SCFHS licensure.
Key Skills for This Role
Responsibilities
- Lead, manage, execute and provide strategic direction to KSA regulatory team
- Provide oversight for KSA, the country team for the Viatris portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans
- Ensure regulatory input is communicated to the 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 in the assigned countries to enable efficient and effective registration of medicinal products
- Ensure business continuity between vertical regulatory teams, Country Regulatory staff and distributors
- Direct line management of Viatris RA team as directed
- 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
- Build incountry relationship with stakeholders/partners and assist team members to do the same
- Manage the performance of direct reports to achieve agreed objectives and identify training and development needs
- Provide input to the regulatory strategy for the development of products in line with business objectives
Requirements
- Bachelor's degree or equivalent in Chemistry, Pharmacy, or a related life sciences
- 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 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
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 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 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 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 req
- 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.
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.
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.
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