Market Access and Regulatory Affairs Director
HybridIstanbul, Istanbul, Turkey
Job Summary
Lead the development and execution of Regulatory Affairs and Market Access strategies to ensure timely submissions, approvals, and full compliance across the portfolio. Shape the external regulatory environment by influencing policy, strengthening partnerships with government authorities, and establishing a robust framework for managing high-quality regulatory documentation. Drive decisions on local Regulatory and Patient Access strategies using insights from cross-functional teams and the global regulatory landscape. Maintain extensive knowledge of product information while communicating evolving Health Authority requirements, legislation, and competitor activities to cross-functional partners. Establish and maintain a strong professional network within Federal, regional, and local government authorities, industry associations, and healthcare providers. Create business cases with the Region/Franchise and develop enhanced compliance processes to improve global submission standards.
Required Qualifications
- Broad experience (>15 years) in Regulatory and Market Access positions supporting biosimilars and/or generics in Turkish Market
- Proven ability to develop trust-based relationships with key regional knowledge of reimbursement processes and commercial principles
- Strong communication, negotiation, influencing, and stakeholder management skills
- English and Turkish (fluent)
- Excellent understanding of local dynamics, including regulatory and market environments and pre-launch activities
- Strong leadership capabilities and people management skills
- Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
Desired Qualifications
- Clinical Trials
- Cross-Functional Teams
- Drug Development
- Lifesciences
- Negotiation Skills
- Problem Solving Skills
- Regulatory Compliance
- Risk Management
- Strategy Execution
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