Foreign Trade Regulatory Affairs Assistant Specialist

Nobel Ilac A.S; Ümraniye; On-site; TRY 240,000 - 320,000; Full time

Job summary

Nobel Ilac A.S in Turkey seeks a Regulatory Affairs Specialist to manage foreign trade regulatory activities, prepare licensing documents, and ensure compliance with local regulations. You will report to the Foreign Trade Regulatory Affairs Team Lead.

You will draft English submissions, coordinate with internal departments to respond to country authorities, monitor regulatory changes, and maintain records of all documents submitted to countries in line with procedures.

Qualifications

• Bachelor's degree in Pharmacy, Chemical Engineering, Chemistry, Biology, Molecular Biology/Genetics or a related field.
• Preferably 1 year of experience in regulatory affairs.
• Proficient in written and spoken English.

Responsibilities

• Prepare applications and variations in English for submission to health authorities of relevant countries.
• Coordinate with business units to respond to questions from country authorities, preparing documentation and following up on the process.
• Monitor regulations of relevant countries and update pharmaceutical dossiers per regulatory requirements.
• Ensure documents submitted to countries are properly recorded and tracked per procedures.

Skills

English proficiency

Regulatory affairs knowledge

Education

Bachelor's degree in Pharmacy, Chemical Engineering, Chemistry, Biology, Molecular Biology/Genetics or related field

Job description

In this role, you will be responsible for regulatory activities for foreign trade markets, preparing and submitting licensing documents, coordinating with internal departments, and ensuring compliance with local regulations. You will report to the Foreign Trade Regulatory Affairs Team Lead.

What You'll Be Doing?

• Preparing applications and variations in English for submission to the health authorities of relevant countries,
• Communicating with business units to respond to questions received from country authorities, preparing relevant documentation and following up on the process,
• Monitoring the regulations of relevant countries and updating pharmaceutical dossiers in line with regulatory requirements,
• Ensuring that relevant documents submitted to countries are properly recorded and tracked in accordance with applicable procedures.

Which Profile Are We Looking For?

• Bachelor's degree in Pharmacy, Chemical Engineering, Chemistry, Biology, Molecular Biology/Genetics or a related field,
• Preferably 1 year of experience the field of regulatory affairs,
• Proficient in written and spoken English.

Nobel is a global player with more than half a century of experience, Nobel was founded in 1954 as a company with 100% Turkish capital.

Nobel operates with a total of 5 facilities, 3 in Türkiye and 1 in each of Kazakhstan and Uzbekistan, while carrying out promotion and sales activities with its own organizations in 24 countries.

Having 4000 employees who are experts in their respective fields, Nobel exports qualified products to 50 countries, which it manufactures according to international standards.

Our Mission is to improve the quality of human life by operating with the motto of “Everything is worth it for health”