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Biogen is seeking a Regulatory Affairs Manager for its Türkiye operations, based in either İstanbul or Ankara. The role involves leading regulatory submission activities, ensuring compliance with local regulations, and collaborating with various stakeholders to support product approvals and lifecycle management.
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Job Summary
The Regulatory Affairs Manager will support the execution of regulatory activities for the assigned portfolio to ensure submissions and approvals of new marketing authorization applications and post-registration variations within agreed timelines.
The role will be responsible for supporting local regulatory operations, including lifecycle management activities, GMP processes, label updates, packaging updates, and communication with Turkish Health Authorities.
You are an experienced Regulatory Affairs professional with strong operational expertise in Türkiye, including dossier preparation, GMP activities, lifecycle management, labeling updates, packaging changes, and Health Authority interactions.
Matching Summary
Match Score: 75
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Biogen is seeking a Regulatory Affairs Manager for its Türkiye operations, based in either İstanbul or Ankara. The role involves leading regulatory submission activities, ensuring compliance with local regulations, and collaborating with various stakeholders to support product approvals and lifecycle management.
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Skills & Requirements
Must-have
Turkish Health Authority communication
Dossier preparation and submission
Lifecycle management activities
GMP strategy and execution
Labeling and packaging compliance
Nice-to-have
Proactive and solution-oriented mindset
Strong cross-functional relationships
Adaptable to evolving environments
Key Requirements
Minimum 5-7 years' experience in Regulatory Affairs in Türkiye
Broad knowledge of Türkiye’s pharmaceutical legislation