Regulatory Affairs Specialist

Baxter Turkey Renal Hizmetler A.Ş.

Who you are

• Bachelor’s Degree in Pharmacy, Biology, Chemistry, Chemical Engineering or equivalent plus specialization in regulatory field
• Minimum 3 years of experience in Regulatory Affairs
• Experience in Global Regulatory Affairs and local MoH systems
• Solid knowledge of DRUG regulations
• Experience in MoH relations and follow up
• Advanced PC use with regards to word-processing, spreadsheets, database applications, internet, sharepoints
• High sense of organization
• Rigor and reliability
• Advanced negotiation skills
• Collaboration and active communication (high interpersonal skills)
• Strategic thinking and proactive management capability
• High sense of customer orientation
• Fluency in English

Job Description

• Manages regulatory activities of new products in order to get products to market according to company plans.
• Handles timely submissions and follow-ups of post-approval labeling and variations.
• Ensures permanent compliance to local regulatory requirements and to Baxter’s policies and procedures.
• Keeps abreast on regulatory environment evolution and challenges, provides advice on resulting strategy.
• Prepares and/or revises relevant SOP's.
• Ensures effective follow up for all MoH submissions.
• Effective management of all related Ministry of Health contacts.
• Builds and develops the relations and enhance MSD reputation on MoH side, and KOL side when deemed necessary.