International Regulatory Affairs Specialist

Biofarma İlaç

Biofarma Pharmaceuticals is a well-established company engaged in pharmaceutical production with 75 years of experience, passion on the first day, dynamic and innovative employees since 1945. It continues to grow and create value for its stakeholders with nearly 700 employees, R&D center while exporting to more than 30 countries.

We as, BİOFARMA İLAÇ SAN. VE TİC. A.Ş, are looking for an "International Regulatory Affairs Specialist”

QUALIFICATIONS

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering or Molecular Biology,
• Minimum of 2 years of experience in Regulatory Affairs experience in International Markets,
• Strong written and verbal communication skills in English,
• Good knowledge on regulatory guidelines in regulated and other countries,
• Excellent communication skills, strong learning, open to teamwork and self-development,
• Proficiency in MS office programs,
• Excellent managing, following up and planning the projects,
• Military service should be completed for male candidates.

JOB DESCRIPTION

• Submission of Marketing Authorization dossiers to Ministry of Health of related countries as per given timeline,
• Follow-up of registration submission dossiers of new products,
• To be proactive for preparation of MA renewal submission dossiers and follow the approval process,
• Follow up variation submissions,
• Following deficiency letters and communicate with related departments to respond properly,
• Coordination and follow up all artwork related issues,
• Prepare and update of SmPCs and PILs of the products,
• Ensuring regulations and guidelines of local and other countries.