Europe & Business Development Regulatory Affairs Specialist

Nobel Ilac A.S; Ümraniye; On-site; TRY 180,000 - 280,000; Full time

Job summary

Nobel Ilac A.S is seeking a Regulatory Affairs professional to lead regulatory activities for overseas markets and coordinate with internal teams. You will prepare licensing documents and translate them into English for submission to health authorities.

Responsibilities include tracking inquiries, monitoring country regulations, and ensuring compliance with procedures. The role requires 2+ years of regulatory experience and strong English skills.

Qualifications

• 2+ years of experience in regulatory affairs.

Responsibilities

• Manage regulatory activities for overseas markets and coordinate with internal departments.
• Prepare and submit licensing documents and translations into English for health authorities.
• Track inquiries from authorities and ensure timely responses with R&D, Quality, Production, Foreign Trade, Purchasing, Import, and Patent.
• Monitor country regulations and revise files to meet country requirements.
• Ensure documentation is properly prepared and sent to countries per procedures.

Skills

English proficiency

Education

Pharmacy, Chemical Engineering, Chemistry, Biology, Molecular Biology/Genetics or similar departments

Job description

In this role, you will be responsible regulatory activities for overseas markets, prepare and submit licensing documents, coordinate with internal departments, and ensure compliance with local regulations. You will report to the Europe & Business Development Regulatory Affairs Team Lead.

What You'll Be Doing?

• Preparing and translating documents, including license applications and renewals, into English for submission to the relevant health authorities for each country,
• Coordinate the tracking of documents prepared for responding to inquiries from authorities by communicating with R&D, Quality, Production, Foreign Trade, Purchasing, Import, and Patent departments,
• Monitor relevant country regulations and revise files according to country requirements,
• Ensuring that documentation is properly prepared and sent to countries, in accordance with procedures,
• Tracking the conduct of processes in accordance with procedures by communicating with countries.

Which Profile Are We Looking For?

• Graduated from Pharmacy, Chemical Engineering, Chemistry, Biology, Molecular Biology/Genetics or similar departments of universities,
• At least 2 years of experience in the field of regulatory affairs,
• Proficient in written and spoken English.

Nobel’s proven excellence in the global pharmaceutical sector is driven by the dedication and expertise of our people. Since 1954, we have grown from our roots in Türkiye into a global pharmaceutical company, thanks to the dedication and expertise of nearly 5,000 colleagues.

We operate 5 R&D and production hubs across Türkiye, Kazakhstan, and Uzbekistan, and our presence spans 24 countries with dedicated local teams. Our multicultural and multinational colleagues embody our global presence, ensuring that our products reach patients in more than 50 countries.

What unites us is our mission: Health for All, Access for All. Every day, we work with passion to improve the quality of human life because at Nobel, every contribution makes a difference.