Regulatory Affairs Specialist - Global Submissions

abbott; Fatih; On-site; TRY 120,000 - 180,000; Full time

Job summary

Abbott in Istanbul seeks a Regulatory Affairs professional to plan, prepare and submit regulatory documentation for new registrations and lifecycle updates. The role partners with global, commercial, medical and manufacturing teams to secure timely approvals and ensure compliance with local regulations.

The candidate will review product information and labeling, support launches, and maintain regulatory records across the lifecycle while ensuring adherence to company standards and regulatory

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or Biology.
• At least two years of regulatory affairs experience.
• Fluent in English (written and spoken).
• Detail oriented with strong follow-up skills.

Responsibilities

• Prepare, compile and submit regulatory dossiers, variations, renewals, labeling updates and other regulatory applications to the Ministry of Health.
• Coordinate with global teams, manufacturing sites and third-party manufacturers for submissions.
• Manage product lifecycle activities including CMC variations and CCDS updates.
• Serve as the primary regulatory contact with health authorities and ensure timely follow-up of submissions and commitments.
• Review product information, labeling and artworks for regulatory compliance.
• Review promotional materials from a regulatory perspective and ensure consistency with approved information.
• Support new product introductions by participating in cross‑functional launch teams and tracking milestones.
• Maintain regulatory databases and documentation systems with accurate records.
• Contribute to development of regulatory procedures and internal training.

Skills

Regulatory affairs experience

English fluency

Attention to detail

Follow-up skills

Education

Bachelor’s degree (Pharmacy/Science)

Job description

Abbott in Istanbul seeks a Regulatory Affairs professional to plan, prepare and submit regulatory documentation for new registrations and lifecycle updates. The role partners with global, commercial, medical and manufacturing teams to secure timely approvals and ensure compliance with local regulations.

The candidate will review product information and labeling, support launches, and maintain regulatory records across the lifecycle while ensuring adherence to company standards and regulatory