Regulatory Affairs Specialist In Istanbul, Turkey

•Prepare Turkish files (chemical and pharmaceutical; pre-clinical and clinical parts) for the registration applications of new products, according to related regulations and guidelines;

•Review, preparation, submission and follow-up of regulatory processes for new products;

•Prepare initial GMP and GMP renewal applications;

•Prepare re-registration and variation applications in order to maintain the registration of marketed products;

•Registeration of medical devices in related database;

•Control and follow up general expenditures during registration activities;

•Support to ensure maintenance of existing registered product portfolio;

•Support to coordinate regulatory and compliance processes according to company and country requirements;

•Deliver regulatory and compliance activities as per agreed timelines;

•Ensure all systems are in place to meet all internal & external requirements.

Qualifications

•Bachelor’s Degree preferably in Pharmacy, Chemistry, Biology, Engineering or related fields;

•Minimum 3+ years Regulatory experience or in a related area in Healthcare industry;

•Excellent planning skills & attention to details;

•Strong multitasking skills & operate in a fast-paced environment;

•Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint;

•Advanced level in written and spoken English.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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