Regulatory Affairs Specialist
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Job Summary
We are looking for Regulatory Affairs Specialist to join our team.
The role is responsible for preparing Turkish regulatory dossiers for the registration applications of new products covering chemical and pharmaceutical products across preclinical and clinical sections in compliance with applicable regulations and guidelines. It also involves reviewing preparing submitting and following up on regulatory processes for new products as well as preparing initial GMP and GMP renewal applications.
The position is responsible for preparing registration and variation applications to ensure the continued registration of marketed products monitoring and following up on general expenditures related to registration activities and supporting the coordination of regulatory and compliance processes in line with company and country-specific requirements.
The role also supports the maintenance of the existing registered product portfolio ensures that regulatory and compliance activities are delivered within agreed timelines and confirms that all systems are in place to meet internal and external requirements.
Qualifications :
Candidates should hold a bachelors degree preferably in Pharmacy Chemistry Biology Engineering or a related field and have a minimum of two years of experience in Regulatory Affairs or a related area within the pharmaceutical or medical devices industry. Excellent planning skills and strong attention to detail are required along with strong multitasking skills and the ability to work effectively in a fast-paced in Microsoft Word Excel and PowerPoint is expected together with advanced written and spoken English proficiency.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
