Medical Regulatory Project Leader

DEVA Holding A.Ş.

Established in 1958, DEVA Holding is among the well-established pharmaceutical manufacturers in Türkiye. With the main area of operations including manufacturing, marketing and exporting medicinal products for human use and raw materials, DEVA Holding also manufactures veterinary medicines, food supplements, cosmetics and medical ampoules.

As part of our Turkey Regulatory Affairs team we are looking for Medical Regulatory Project Leader:

QUALIFICATIONS

• University degree in Pharmacy, Chemistry, Bioengineering, Biology etc.
• Minimum 5 years of experience in Medical, Pharmacovigilance or Regulatory Departments
• Excellent verbal and written communication skills in Turkish and English
• Effective communication style
• Proficiency in MS Office
• Good in teamwork and cross functional collaboration
• Result oriented, strong in data gathering and interpretation
• Proactive, positive and innovative mindset
• No military obligation for male candidates

JOB DESCRIPTION

• As part of Turkey Medical Regulatory team will contribute to Medical  and Risk Management Plan activities
• Review of pharmacoepidemiological data for reimbursement applications and clinical parts for the regulatory submissions.
• Preparation and updating SMPC/PILs for new & marketed reference / equivalent products referring to EMA, FDA, EMC, TITCK web pages.
• Understanding and implementing all relevant regulatory requirements
• Actively communicate and ensure alignment with internal and external stakeholders