Regulatory Affairs Specialist (Contractor)

Pfizer Türkiye

QUALIFICATIONS 

• Scientific degree from Pharmacy, Biology, Chemistry or Chemical Engineering departments
• Appropriate regulatory experience min 1 year
• Have a good command of written and spoken English
• Have good Planning and coordination skills
• Have good communication-influencing skills.
• Be familiar with legislation governing the activities of the pharmaceutical industry.
• Be computer literate (Word, Excel, PowerPoint, etc.)

JOB DESCRIPTION 

• Preparation of the New Drug Application (NDA) and ensuring that all required documentation in compliance with MoH regulations is generated, collected, delivered and filed during the registration process.
• Follow up of the registration process through MoH
• Archive all registration relevant documents
• Ensure timely completion of all lifecycle maintainance activities (variations, renewals, etc.) for the products
• Ensure local label updates are completed according to the timelines defined in the SOPs
• Update the electronic global and local databases according to the current SOPs.
• Notify local and global partners about the registration status.
• Ensure continuous communication with global strategists.
• Prepare GMP dossiers, follow up processes before- throughout & after inspections.
• Follow up and ensure that all GMP renewal submissions are completed on time.
• Follow up the local guidelines and implement new updates.
• Check package & leaflets to ensure complaince.
• Follow-up of all outstanding applications and queries.
• Respond to spontaneous requests from authorities promptly and accurately
• Completion and follow-up of assigned tasks for ongoing projects.