Regulatory Affairs Specialist

Bilim İlaç San. ve Tic. A.Ş.

''Founded in 1953, Bilim İlaç is a wholly Turkish-owned company specializing in the manufacturing and distributing of strategically vital pharmaceuticals. Operating from two state-of-the-art facilities in Gebze and Çerkezköy, Bilim İlaç exports to over 70 countries worldwide.

In our country, Bilim İlaç ranks among the top four companies with the highest sales in three of the top five segments and the highest sales volumes: antibiotics, respiratory system drugs, and musculoskeletal system medications. Of its 480 licensed drugs, approximately 200 are actively available on the market.

Placing customer satisfaction at its core, Bilim İlaç conducts sales and marketing activities with over 1,000 field employees across 11 regions throughout Turkey. The company continues its efforts to add value to human health in every corner of the nation.'

Our company is seeking a "International Markets Regulatory Affairs Specialist" to be assigned to the Regulatory Affairs Department at our Bilim Plaza (Beyoğlu) location. The job description and the qualifications required for suitable candidates are outlined below.

Job Description:

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

Qualifications:

• Graduated from universities' Pharmacy, Chemistry, Chemical Engineering, or related departments.
• At least 2 years of experience in the pharmaceutical industry, especially in international markets regulatory affairs.
• Proficient in English.
• Experienced in preparing dossiers in CTD format.
• Proficient in MS Office programs.
• Developed analytical thinking and problem-solving skills.
• Strong communication and negotiation skills.
• Team-oriented with high organizational and planning abilities.
• For male candidates, completion of military service is required.