Senior Local Regulatory Affairs Specialist – Ankara

Parexel; Turkey; Remote; TRY 450,000 - 750,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Vacation/Holiday/Sick Time

Flexible benefit portal

Job summary

Parexel is seeking an experienced Senior Local Regulatory Specialist/Associate based in or within commuteable distance to Ankara to support regulatory operations in local markets. This role will involve in person meetings with Health Authority representatives and serve as a key liaison between health authorities, regulatory stakeholders and regional functions.

You will help with product registrations, lifecycle management, regulatory compliance and health authority engagement while ensuring

Qualifications

• Relevant bachelor's degree in biology, chemistry or related field with pharmacological focus.
• 5+ years Turkish regulatory experience in health authority facing roles.
• Strong understanding of regional and global regulatory requirements and processes.
• Experience managing regulatory submissions, timelines and cross functional activities.
• Expertise in local health authority engagement and management.
• Strong communication, organization and problem-solving in a global environment.
• Fluent in Turkish and English, both written and verbal.
• Advanced Microsoft Office skills.

Responsibilities

• Provide local regulatory input to support development and execution of strategies for new product registrations and lifecycle management.
• Ensure compliance with local regulatory requirements and participate in policy activities with industry groups.
• Maintain current knowledge of local regulatory guidelines and communicate changes to stakeholders.
• Support interactions with health authorities, partners and vendors, representing regulatory interests.
• Prepare, organize, and coordinate local regulatory documentation and submissions components.
• Support implementation of local legislation, interpretation of regulations, and promotional material review.
• Collaborate with regional regulatory teams for planning and execution of submissions per local requirements.
• Act as regulatory representative for local commercial operations and communicate approvals.
• Maintain regulatory information systems and monitor compliance for renewals and post-approval actions.
• Support labeling activities, updates, translations, and promotional material reviews.

Skills

Regulatory affairs

Health authority

Regulatory submissions

Cross-functional collab

Regulatory risk mgmt

Regulatory information mgmt

English fluency

Turkish language

Education

Bachelor's degree in a scientific discipline

5+ years Turkish regulatory experience

Job description

Parexel is seeking an experienced Senior Local Regulatory Specialist/Associate based in or within commuteable distance to Ankara to support regulatory operations in local markets. This role will involve in person meetings with Health Authority representatives and serve as a key liaison between health authorities, regulatory stakeholders and regional functions.

You will help with product registrations, lifecycle management, regulatory compliance and health authority engagement while ensuring