Regulatory Affaırs Specıalıst/Ass. Specıalıst

Güneşli A.Ş

Role requirements 

• Preparing and supporting applications to obtain marketing authorizations. 

• Maintaning marketing authorizations (Life cycle management activities like renewals, new indications, line extension, variations, etc.) and keeping related Gunesli systems and databeses up to date in timely manner. 

• Follow- up registration steps during the Marketing authorizations process (the entire registration phase such as the submission, evaluation, analyzing, sales permission, etc)

• Providing full regulatory support across the related line units

• Assists the GMP coordinator for product specific documentation

• Maintaining complete archvie of all MoH /Local / Global business communications and documentation

• Import / Export 

• Assists the International Regulatory coordinator for products in relevant countries 

WHO YOU ARE 

• A strong sense of ownership and accountability

• Strong follow-up & tracking skills 

• High degree of self- organizations and detail-orientation 

• Advanced level of MS Office applications

• Strong communication skills both in Turkish and English