Full-Time Regulatory Affairs Manager - Türkiye

About This Role Joining us as Regulatory Affairs Manager, you will collaborate closely with the Türkiye Regulatory and commercial organization, International Growth markets (IGM) team, Global Regulatory Affairs (GRA), and Chemistry, Manufacturing and Control (CMC) Regional contacts, and relevant local stakeholders.

What You’ll Do

• Registration Planning: Develop and execute registration strategy & plans for assigned products, aligning with regional strategy, business plans, and objectives. Provide input on anticipated market-specific regulatory issues for planned submissions, local strategic guidance, insights, and interpretation, and updates related to Türkiye markets based on local laws, requirements, and market practice.
• Dossier preparation, submission, and product Approval: Ensure execution of agreed plans by coordinating compilation of local application files based on IGM regional team documentation, according to local regulations. Follow up with TİTCK/MoH evaluation processes, addressing their demands by proactively managing risks & threats.
• Support Market-specific file compilation and preparation: Responsible for leading country regulatory submission activities for new products (CTD dossier preparation) & life-cycle management of registered products.
• GMP: Design a GMP strategy for earliest access, prepare & submit GMP file, and closely follow-up with TİTCK/MoH for timely approval. Maintain GMP certificates, initiate GMP renewals.
• Regulatory Compliance: Ensure local and internal compliance with regulatory processes and systems. Maintain product licenses and ensure compliance of marketed products with local and corporate requirements. Initiate, manage, and oversee labelling/artwork development, review, approval, and implementation within timelines and local Health Authority regulations.
• Regulatory intelligence: Identify current & emerging national regulations impacting marketing processes, promptly informing relevant parties to add value to company objectives. Provide competition intelligence and interpretation of business impact.
• Regulatory Influence: Establish and maintain regular, strong, and trustworthy relationships with regulatory officials, communicate with local distributors to ensure optimized and compliant regulatory procedures.

Who You Are

• Detail-oriented regulatory professional with proven expertise in managing complex regulatory processes in Türkiye.
• Strong strategic thinking, communication skills, and understanding of local pharmaceutical regulations, building trusted relationships.

Required Skills

• Health-related sciences background (B.A./B.S., Masters' preferred).
• Minimum 5-7 years’ experience in Regulatory Affairs in Türkiye.
• Proven strategic regulatory thinking, risk assessment capability, and knowledge of Türkiye's pharmaceutical legislation.
• Strong ability to interpret and apply local regulations, guidelines, and influencing/advising operations accordingly.
• Experience with biotech products in neurology or complex therapy areas.
• Proven track record of fast-track registrations in Türkiye.
• Effective interaction with regulatory agencies & external network.
• Strong analytical skills, accuracy, and reliability. Strong communication skills.

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