Regulatory Affairs & Compliance Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Istanbul, Istanbul, Turkey, Istanbul, Turkey

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Regulatory Affairs & Compliance Specialist to be based in Istanbul / Türkiye.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

This role is responsible for supporting the execution and continuous improvement of the Quality Management System within TURGAN (Türkiye, Ukraine, Azerbaijan, Georgia) with primary focus on product quality complaints, suspect/counterfeit/tampered product management, supplier quality processes, and training management. The position also provides support across QMS processes and acts as backup for release-related activities when needed.

Key Responsibilities

• Execute regulatory submissions (registrations, variations, renewals) and support product lifecycle management
• Ensure compliance with local regulations, GxP standards, and company SOPs; maintain inspection-ready documentation
• Support audit and inspection readiness, including responses to Health Authority queries and CAPA tracking
• Maintain regulatory documentation and manage data in regulatory and quality systems
• Monitor regulatory changes and support implementation across the portfolio
• Collaborate cross-functionally (Medical, Safety, Quality, Supply Chain) to ensure compliance and supply continuity

Qualifications:

• Bachelor’s degree in Life Sciences/Pharmacy;
• Min 5 years in Regulatory Affairs or compliance (pharma preferred)

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented