Turkish Regulatory Affairs Specialist: Dossier & Compliance

Vochure; Fatih; On-site; TRY 180,000 - 280,000; Full time

Job summary

AbbVie is seeking a Regulatory Affairs Specialist in Turkey to prepare Turkish regulatory dossiers for registration of new products across chemical and pharmaceutical categories. The role covers preclinical and clinical sections, with responsibilities for reviewing, submitting and following up on regulatory processes, and preparing GMP applications.

Strong English skills and meticulous planning are required.

Qualifications

• Bachelor's degree in a relevant field (Pharmacy, Chemistry, Biology, Engineering or related)
• Minimum of two years of regulatory affairs or related experience in pharma/medical devices
• Excellent planning, attention to detail and ability to multitask in a fast-paced environment

Responsibilities

• Prepare Turkish regulatory dossiers for registration of new products
• Review, submit and follow up on regulatory processes for new products
• Prepare initial GMP and GMP renewal applications
• Prepare registration and variation applications to maintain marketed products
• Coordinate regulatory/compliance activities in line with company and country requirements
• Maintain existing registered product portfolio and ensure timely regulatory delivery

Skills

Regulatory affairs

Attention to detail

Multitasking

English proficiency

MS Office

Education

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

Tools

Microsoft Word

Excel

PowerPoint

Job description

AbbVie is seeking a Regulatory Affairs Specialist in Turkey to prepare Turkish regulatory dossiers for registration of new products across chemical and pharmaceutical categories. The role covers preclinical and clinical sections, with responsibilities for reviewing, submitting and following up on regulatory processes, and preparing GMP applications.

Strong English skills and meticulous planning are required.