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Regulatory Affairs Senior Manager
Viatris Inc
Riyadh, KSA
Full Time
Manager
4 weeks ago
Regulatory AffairsSAMA RegulationsCMC SubmissionsProduct Lifecycle ManagementLeadershipCommunication
Free
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Regulatory AffairsSAMA RegulationsCMC Submissions
About the Role
Viatris is seeking a Regulatory Affairs Senior Manager to lead the KSA regulatory team in Riyadh. The role requires a Bachelor's degree in life sciences, 10+ years of regulatory affairs experience in pharmaceuticals, and Saudi nationality with SCFHS license.
Key Skills for This Role
Regulatory AffairsSAMA RegulationsCMC SubmissionsProduct Lifecycle ManagementLeadershipCommunication
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
- Develop and execute regulatory strategies, processes, and plans in support of new registrations and post approval submissions
- 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
- Ensure business continuity between vertical regulatory teams, Country Regulatory staff and distributors
- Direct line management of Viatris RA team as directed
- Manage the performance of direct reports to achieve agreed objectives and identify training needs
- Provide input to the regulatory strategy for the development of products in line with business objectives
- Facilitate and support all product lifecycle regulatory work
- Ensure and oversee the preparation of regulatory strategies and plans for assigned countries
Requirements
- Bachelor’s degree or equivalent in Chemistry, Pharmacy, or 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
- 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.
- 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 incountry 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, etc.
- Facilitating and support all product lifecycle regulatory work.
- Ensure and oversee the preparation of regulatory strategies and plans for assigned countries.
- Advise, where necessary, with direct reports and Vertical Regulatory teams the receipt, distribution and response to regulatory queries.
- Develop detailed understanding of regulatory guidelines and technical requirements.
Education & 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.
- 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.
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