Regulatory Affairs Specialist
Abbott
Türkiye - İstanbulPosted Discovered via the company's careers siteMatch locked
Full time2+ years exp
JOB DESCRIPTION
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
The Opportunity
This position works at Istanbul location in the Established Pharmaceuticals Division that we are committed to bringing the benefits of our trusted medicines to more people in the world's fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. .
MAIN PURPOSE OF ROLE
Regulatory Affairs professional responsible for planning, preparing and submitting regulatory documentation to support new product registrations, lifecycle management activities and labeling updates. Works cross-functionally with global, commercial, medical and manufacturing teams to ensure timely regulatory approvals, compliance with local regulations and successful product launches.
MAIN RESPONSIBILITIES
- Prepare, compile and submit regulatory dossiers, variations, renewals, labeling updates and other regulatory applications to the Ministry of Health in accordance with local requirements and business priorities.
- Coordinate with global teams, manufacturing sites and third-party manufacturers to obtain and review regulatory documentation required for submissions.
- Manage product lifecycle activities, including CMC variations, CCDS updates, responses to deficiency letters and maintenance of marketing authorizations.
- Serve as the primary regulatory contact with health authorities and ensure timely follow-up of submissions, approvals and regulatory commitments.
- Review and maintain product information, including Summary of Product Characteristics, Patient Information Leaflets, artworks and labeling materials, ensuring compliance with local regulations and company standards.
- Review promotional materials from a regulatory compliance perspective and ensure consistency with approved product information.
- Support new product introductions by participating in cross-functional launch teams, monitoring project timelines and ensuring regulatory milestones are achieved.
- Maintain regulatory databases and documentation systems, ensuring accuracy and timely updates of product records.
- Contribute to the development and implementation of regulatory procedures, process improvements and internal training activities.
- Track regulatory projects and KPIs, ensuring timely execution of commitments and alignment with business objectives.
Required Qualifications
- Bachelor's degree, p referably in Pharmacy, Chemistry, Chemical Engineering, Biology
- Minimum two years of experience in regulatory affairs
- Fluency in English (written and spoken).
- D etail oriented, strong follow-up skills
Apply Now
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/A In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Regulatory Operations
DIVISION
EPD Established Pharma
LOCATION
Türkiye > Istanbul : Saray Mah Dr Adnan Buyukdeniz Cd Umraniye
WORK SHIFT
Standard
TRAVEL
Not specified
MEDICAL SURVEILLANCE
Not Applicable
SIGNIFICANT WORK ACTIVITIES
Not Applicable
Not included in the source posting: about the role, benefits.
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
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