Regulatory Affairs Specialist (15 Months Contract)

Pfizer Türkiye

Reports to: Head of Regulatory Affairs Turkey, Upjohn GRA

Primary Responsibilities

• Following up the new product registration process and ensuring coordination with legal division in order to protect intellectual property rights and data exclusivity.
• Ensuring continuous communication with MoH, official institutions, commitees and associations.
• Filing and storage of all registration relevant documents in the appropriate folders as determined in relevant SOPs.
• Demanding information and documents, required for new product registration application.
• 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.
• Translation / ensuring the translation of required documents into local language.
• Ensuring that all files are correctly maintained and secured.
• Follow up of the registration process through MoH and related Opinion Leaders.
• Updating the electronic global and local databases periodically.
• Notifying related personnel and NYHQ about the registration status.
• Develop & plan regulatory strategy for new products & current MAs in cooperation with global and related departments at PCO.
• Prepare Type I & II variations.
• Prepare renewal dossiers.
• Prepare and update SmPC & PIL.
• Make necessary correspondence with global strategists.
• Prepare GMP dossiers, follow up GMP procedures before- throughout & after inspections.
• Follow up the guidelines and make necessary correspondence with authorities.
• Follow up all correspondences with BoH to get approvals.
• Control of package & leaflets.
• Attend to the GMP inspections as a Pfizer representative.
• Follow-up of outstanding applications and queries with business focus.
• Communication with Authorities on Product Registration issues as required
• Respond to spontaneous requests from authorities promptly and accurately ensuring that all relevant in house liaison has taken place to avoid misinformation or communication breakdown.

Qualifications 

• Scientific degree 
• Have a good command of written and spoken English
• Be computer literate (Word, Excel, PowerPoint, MS Project, Acrobat, INTERNET, INTRANET, etc.)
• Have good presentation skills
• Be familiar with legislation governing the activities of the pharmaceutical industry.
• Have good communication-influencing skills.
• Grows self
• Deliver results