Regulatory Affairs Specialist

Bilim İlaç; Beyoğlu; On-site; TRY 167,000 - 234,000; Full time

Job summary

Bilim Pharmaceuticals in Beyoğlu, Turkey, seeks a Regulatory Affairs Specialist to join the Regulatory Affairs Department at Bilim Plaza. You will plan and manage regulatory processes for products in international markets and prepare EU-CTD dossiers by monitoring country regulations.

You will establish effective communication with authorities and partners, coordinating with R&D, production, and QA to ensure proper documentation and filing.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or related departments.

Responsibilities

• Plan and manage the regulatory processes for our products in targeted international markets.

Skills

English proficiency

EU-CTD format experience

MS Office

Regulatory communication

Regulatory submissions

Team collaboration

Analytical/problem-solving

Planning and organization

Education

Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or related departments

Tools

MS Office

Job description

A Career Journey that Adds Value to Life with Bilim Pharmaceuticals

Established in 1953 with 100% Turkish capital, Bilim Pharmaceuticals stands as one of the foremost leaders in the Turkish pharmaceutical industry. With state-of-the-art manufacturing facilities in Gebze and Çerkezköy, a dedicated team of over 2,500 professionals, and a portfolio of more than 200 licensed products, we proudly advance human health in Turkey and extend our expertise to over 70 countries worldwide.

Ranked among the top three of nearly 500 pharmaceutical companies operating in Turkey, we continue to grow with strength and stability — driven by operational excellence and a steadfast commitment to improving quality of life.

We are seeking a "Regulatory Affairs Specialist" to join our Regulatory Affairs Department at Bilim Plaza (Beyoğlu).

Qualifications:

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or related departments
• Preferably at least 2–3 years of experience in the pharmaceutical industry, especially in international market regulatory affairs
• Advanced proficiency in English, both written and spoken,
• Experienced in preparing dossiers in EU-CTD format
• Proficiency in MS Office programs
• Strong analytical and problem-solving skills
• Strong communication and negotiation skills
• Team-oriented with high organizational and planning abilities

Job Description:

• Plan and manage the regulatory processes for our products in targeted international markets.
• Prepare and submit regulatory dossiers in EU-CTD format by monitoring country-specific regulations and legislations
• Execute and monitor license renewals and variation applications
• Establish effective communication with relevant official authorities and business partners to ensure smooth progress of processes
• Coordinate with internal departments (R&D, Production, Quality Control, etc.) to ensure the preparation and updating of necessary documentation
• Manage product labeling and packaging processes according to market requirements
• Keep track of current developments and changes related to regulatory processes and provide internal company updates

In connection with your job application to Bilim İlaç Tic. A.Ş. (“Bilim Pharmaceuticals”), any personal data you provide will be processed by Bilim Pharmaceuticals, as the data controller, in compliance with the Personal Data Protection Law No. 6698. This processing is done to collect, evaluate, and manage recruitment activities. For more information on how Bilim Pharmaceuticals processes your data, please visit: https://www.bilimilac.com.tr/en/protection-of-personal-data