Regulatory Affairs Specialist

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

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

The Opportunity

This position works at Istanbul location in the Established Pharmaceuticals Division that we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. .

What You’ll Do

MAIN PURPOSE OF ROLE

Regulatory Affairs professional responsible for planning, preparing and submitting regulatory documentation to support new product registrations, lifecycle management activities and labeling updates. Works cross-functionally with global, commercial, medical and manufacturing teams to ensure timely regulatory approvals, compliance with local regulations and successful product launches.

MAIN RESPONSIBILITIES

• Prepare, compile and submit regulatory dossiers, variations, renewals, labeling updates and other regulatory applications to the Ministry of Health in accordance with local requirements and business priorities.
• Coordinate with global teams, manufacturing sites and third-party manufacturers to obtain and review regulatory documentation required for submissions.
• Manage product lifecycle activities, including CMC variations, CCDS updates, responses to deficiency letters and maintenance of marketing authorizations.
• Serve as the primary regulatory contact with health authorities and ensure timely follow-up of submissions, approvals and regulatory commitments.
• Review and maintain product information, including Summary of Product Characteristics, Patient Information Leaflets, artworks and labeling materials, ensuring compliance with local regulations and company standards.
• Review promotional materials from a regulatory compliance perspective and ensure consistency with approved product information.
• Support new product introductions by participating in cross-functional launch teams, monitoring project timelines and ensuring regulatory milestones are achieved.
• Maintain regulatory databases and documentation systems, ensuring accuracy and timely updates of product records.
• Contribute to the development and implementation of regulatory procedures, process improvements and internal training activities.
• Track regulatory projects and KPIs, ensuring timely execution of commitments and alignment with business objectives.

Required Qualifications

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

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

EPD Established Pharma

LOCATION:

Türkiye > Istanbul : Saray Mah Dr Adnan Buyukdeniz Cd Umraniye

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable