Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Job Description
Prepare Turkish files (chemical and pharmaceutical; preclinical and clinical parts) for the registration applications of new products according to related regulations and guidelines
Review preparation submission and followup of regulatory processes for new products
Prepare initial GMP and GMP renewal applications
Prepare reregistration and variation applications to maintain the registration of marketed products
Control and follow up general expenditures during registration activities
Support to coordinate regulatory and compliance processes according to company and country requirements
Support to ensure maintenance of existing registered product portfolio
Deliver regulatory and compliance activities as per agreed timelines
Ensure all systems are in place to meet all internal & external requirements.
Qualifications :
Bachelors degree preferably in Pharmacy Chemistry Biology Engineering or related fields
Minimum 2 years Regulatory experience or in a related area in Healthcare industry
Excellent planning skills & attention to details
Strong multitasking skills & operate in a fastpaced environment
Computer skills including proficiency in use of Microsoft Word Excel and PowerPoint
Advanced level in written and spoken English.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies 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.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
