Regulatory Affairs Specialist: Turkish Dossier Expert

AbbVie; Fatih; On-site; TRY 250,000 - 350,000; Full time

Job summary

AbbVie in Turkey is seeking a Regulatory Affairs Specialist to prepare Turkish regulatory dossiers for the registration of new products, including chemical and pharmaceutical products, across preclinical and clinical sections in accordance with applicable regulations.

The role involves reviewing, preparing, submitting, and tracking regulatory processes for new products, as well as preparing GMP and GMP renewal applications and maintaining the portfolio to meet internal and external requirements.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field.
• Minimum of two years of experience in Regulatory Affairs or related area in pharma/medical devices.
• Advanced written and spoken English required.

Responsibilities

• Prepare Turkish regulatory dossiers for registration applications of new products.
• Review, prepare, submit, and follow up on regulatory processes for new products.
• Prepare initial GMP and GMP renewal applications.
• Maintain the registered product portfolio and ensure regulatory activities meet timelines.

Skills

Regulatory affairs

Attention to detail

English proficiency

Multi-tasking

Education

Bachelor’s degree

Tools

MS Office

Regulatory databases

Job description

AbbVie in Turkey is seeking a Regulatory Affairs Specialist to prepare Turkish regulatory dossiers for the registration of new products, including chemical and pharmaceutical products, across preclinical and clinical sections in accordance with applicable regulations.

The role involves reviewing, preparing, submitting, and tracking regulatory processes for new products, as well as preparing GMP and GMP renewal applications and maintaining the portfolio to meet internal and external requirements.