CMC Regulatory Affairs Executive İş İlanı

QUALIFICATIONS AND JOB DESCRIPTION

Bilim Pharmaceuticals, which started its operations in 1953, is a 100% Turkish-funded company that produces and markets pharmaceuticals, a strategic priority. Bilim Pharmaceuticals conducts its production in two separate facilities located in Gebze and Çerkezköy and exports to more than 70 countries. Bilim İlaç has always been in the top-three pharmaceuticals company in its segments and has continuous growth while accomplishing its strategic targets in the Turkish pharmaceuticals sector, in which there are 500 competitor pharmaceuticals company.

Bilim İlaç is looking for a “CMC Regulatory Affairs Executive” for Regulatory Affairs Department.

A brief job description of the position and preferred qualifications for the suitable candidates are defined below.

• Degree in Chemistry, Biology and Chemical Engineering,
• 7 years of similar experience in pharmaceutical industry. EU dossier preparation experience preferred,
• Have practical and theoretical knowledge on subjects such as drug development,GMP, GLP, Quality on pharmaceutical production,
• Broad knowledge of CMC regulatory requirements (EU, US, ICH and other relevant guidelines), EU as well as US Pharmacopoeias and GMP regulations,
• Have good communication, organization and negotiation skills, strong leadership skills,
• Excellent oral and written communication in English,
• Experience with managing contract labs,
• No military obligation for male candidates.

JOB DESCRIPTION

• Follow scientific arguments, identify scientific data needs for licensing, and solve regulatory issues,
• Review CMC documents, develop CMC regulatory strategies, provide risk assessments,
• Coordinating and contributing to the writing, maintenance and submission of regulatory CMC documents in line with guidelines and regulations, including variations,
• Providing input as a technical expert on authority questions concerning CMC/Module 3 documentation and regulations.