Market Access and Regulatory Affairs Director

About the role

The Market Access and Regulatory Affairs Director will shape the external regulatory environment and drive the strategic positioning of Sandoz in Turkey. This senior leader will develop and execute regulatory and market access strategies to ensure timely submissions, approvals, patient access, pricing, and full compliance across the portfolio.

Key responsibilities

• Lead the creation and implementation of Regulatory Affairs and Market Access strategies for biosimilars and generics.
• Maintain a robust framework for managing, compiling, submitting, and obtaining approval of high‑quality regulatory documentation.
• Advise project teams on local submission requirements and stay abreast of evolving health authority regulations.
• Influence policy, build relationships with government authorities, industry associations, healthcare providers, and health‑economic organisations.
• Communicate regulatory changes, legislation, and competitor activities to cross‑functional teams.
• Develop business cases with regional and franchise partners and ensure alignment with global submission standards.
• Oversee implementation and optimal use of regulatory systems and tools, ensuring compliance with agency guidelines.
• Contribute to departmental goal setting, budget adherence, and performance monitoring.

Required profile

• More than 15 years of experience in regulatory and market access roles supporting biosimilars or generics in the Turkish market.
• Proven ability to build trust‑based relationships with regional stakeholders and deep knowledge of reimbursement processes and commercial principles.
• Fluent in English and Turkish with strong communication, negotiation, and influencing skills.
• Excellent understanding of local healthcare dynamics and regulatory landscape.

Required skills