Regulatory Affairs Specialist: Turkish Dossiers & Compliance

AbbVie Inc.; Fatih; On-site; TRY 350,000 - 550,000; Full time

Job summary

AbbVie Turkey is seeking a Regulatory Affairs Specialist to prepare Turkish regulatory dossiers for registration of new products, covering chemical and pharmaceutical products, in line with regulations. You will review, submit, and follow up on regulatory processes and support GMP applications.

The role includes maintaining the registered product portfolio, ensuring timely regulatory deliverables, and coordinating compliance activities across country requirements.

Qualifications

• Bachelor's degree in a related field and at least 2 years in Regulatory Affairs.
• Strong planning and attention to detail in a fast-paced environment.
• Proficiency in Word, Excel, and PowerPoint; advanced English proficiency.

Responsibilities

• Prepare Turkish regulatory dossiers for registration of new products.
• Review, prepare, submit and follow up regulatory processes.
• Prepare initial GMP and GMP renewal applications.

Skills

Planning skills

Attention to detail

Multitasking

MS Word

MS Excel

MS PowerPoint

English proficiency

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering or related field

Job description

AbbVie Turkey is seeking a Regulatory Affairs Specialist to prepare Turkish regulatory dossiers for registration of new products, covering chemical and pharmaceutical products, in line with regulations. You will review, submit, and follow up on regulatory processes and support GMP applications.

The role includes maintaining the registered product portfolio, ensuring timely regulatory deliverables, and coordinating compliance activities across country requirements.