Regulatory Specialist (1 Year Contract)

GENSENTA İLAÇ SAN. VE TİC. A.Ş.
City: İstanbul(Avr.)

Advertisement Date:06.05.2021

Qualifications

Job Description: 

• Ensure necessary requirements in Regulatory process and archive.
• Manage pre-submission and post-submission regulatory process of the products in line with the countries’ regulations; prepare the necessary documentation for regulatory files and follow-up. (MA dossier preparation and submission, deficiency letter responses, type variation and renewal submissions, GMP submissions, SmPC&PIL and artwork submissions, make verbal and written correspondence with authorities and etc.).
• Understand regulations and the authority’s approaches and apply regulatory strategies as needed.
• Ensure timely registration of products for new marketing authorization submissions and for granted marketing authorizations in compliance with applicable regulation and guidelines.
• Determine necessary actions to be taken for the registration process based on the authority’s regulations and coordinate necessary meetings and making correspondences with the related departments.
• Organize and follow daily/monthly personal work list in accordance with the company business plans.
• Compose, update and apply Standard Operating Procedures (SOP) of Regulatory Affairs department.

General Qualifications: 

• University degree in related departments (Chemist, Chemical Eng., Pharmacy, etc.),
• Preferably minimum 4-5 years of Regulatory Affairs experience in industry,
• Fluency in English, both oral and written communications,
• Computer skills (MS Office programs),
• Strong planning, coordination, negotiation and communication skills,
• Strong analytical mind and problem-solving skills,
• Result oriented and proactive,
• Multi-task oriented and ability to work with cross-functional team.

Job Description