Regulatory Affairs Department Assistant

Merck Sharp & Dohme

• University graduate
• Minimum 3 years of experience in Regulatory Affairs department is preferred
• Must be able to work alone and as part of a team
• High sense of organization
• Rigor and reliability
• Negotiation skills
• English fluency
• Good knowledge of MS Office
• Strong planning and organizing skills

İŞ TANIMI

• Archiving of all Regulatory Files
• Support regulatory correspondence and compliance
• Training Coordinator for Turkey Regulatory Team
• Support Quality Manager in quality operations
• Administrative Support

• Organization of the archive rooms with the facility management.
• Organizes the transfer to and from the office to relevant file locations.
• Organize and update the hardcopy regulatory files naming conventions.

• Management of Ministry of Health daily correspondences.
• Registration in the tracking sheet, distribution to related specialists daily.
• Organize and courier all Ministry of Health letters daily to Regulatory Manager in Ankara.

• Manage the training curriculum for each role
• Follow up of all new trainings, assign relevant trainings directed by MEA Training coordinator to the team members, report the completion status via achieving training certificates

• Keeping training records of entire department.
• Organization and management of Regulatory Department local SOPs.
• Creation of related SOPs if needed.

• Handle different orders with suppliers. Once the order is placed, keeps close follow up with the supplier (air tickets, hotel accommodation, materials for LNCM control, registration fees for trainings, translations, ...) in order to have the goods on time and follow up of their invoices with the purchasing and finance department for payment.
• Support in following the Regulatory Department budget. Follow-up budget on regular basis in close collaboration with Regulatory Affairs Director and Finance.
• Organization and transaction of all local registration fees timely in cooperation with Finance department.
• Organization of all translations of regulatory documents with the relevant suppliers.
• Regularly checks stationary stocks and ensures stocks are available.