Market Access and Regulatory Affairs Director

Job Description Summary

Market Access and Regulatory Affairs Director shape the external regulatory environment and drives strategic positioning of the company, leads the development and execution of Regulatory Affairs and Market Access strategies to ensure timely regulatory submissions and approvals, patient access, pricing, and full regulatory compliance across the portfolio.

Act as key external facing leader to shape the healthcare environment, influence policy and strengthen partnerships with government authorities and key stakeholders.

Job Description

Market Access and Regulatory Affairs Director shape the external regulatory environment and drives strategic positioning of the company, leads the development and execution of Regulatory Affairs and Market Access strategies to ensure timely regulatory submissions and approvals, patient access, pricing, and full regulatory compliance across the portfolio.

Act as key external facing leader to shape the healthcare environment, influence policy and strengthen partnerships with government authorities and key stakeholders.

Job Description

• •Maintains extensive knowledge of product information and regular contact with local, regional, and divisional customers.
• •Provides a robust framework to oversee the management, compilation, and timely dispatch, submission, and approval of high quality regulatory documentation.
• •Provides advice to project teams on local regulatory submission requirements.
• •Stays on the pulse of evolving Health Authority requirements, ensuring Sandoz is influencing and shaping policy in this area and building strategies to proactively prepare the organization for the future.
• •Drives decisions related to Regulatory and Patient Access strategies at a local level.
• •Utilizes insights from cross functional teams, market research, and the Regulatory landscape (locally, regionally and globally) to develop and implement high quality Regulatory and Patient Access strategic and operational plans.
• •Establishes and maintains a strong professional network within the Federal /Regional and local Government authorities, Industry Associations, Healthcare providers, Health Economic organizations and other relevant lobbying and decision-making representatives.
• •Communicates relevant changes and trends in local regulations, legislation, health policies, and competitor Patient Access activities of new competitors to the cross functional team.
• •Creates and works with the Region/Franchise to agree Business Cases.
• •Develops and implements enhanced compliance /process efficiencies to global submission preparation standards, strategies and related procedures/tools.
• •Ensures global cross-functional business/IT/external partners adopt and adhere to the locally established submission/document standards, and policies.
• •Oversees the local implementation and optimal use of Regulatory systems and tools.
• •Ensures compliance with the requirements/guidances from regulatory agencies.
• •Contributes to and leads to the development of departmental goals and objectives.
• •Strong leadership capabilities and people management skills.
• •Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.

Minimum Requirements:

• •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.

• Why Sandoz?
• Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

• Commitment To Diversity & Inclusion
• We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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Skills Desired

Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution