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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Regulatory Affairs Manager

Istanbul, Turkey Req ID 2205323 Category Regulatory Affairs Division AbbVie

Reporting to Head of Regulatory Affairs, the incumbent will be responsible for;

As an active Brand Team member actively contribute to brand strategies working with other functions by ensuring a balanced approach between his/her function's and the overall Brand Team's benefit.
Ensure appropriate coordination with Area/Region RA teams to review the originating data, coordinate and obtain all the certificates and documents necessary for applications and MOH requirements.
Control the prepared Turkish files (chemical and pharmaceutical; pre-clinical and clinical parts) for the registration applications of new products, according to the Registration Dossier Preparation SOP.
Develop, implement and maintain submission delivery plans, content plans, and proactively provide status updates including regulatory risks and mitigation strategies to designated partners.
Coordinate the input, maintenance and revision in project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner.
Use and share the best methods during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
Coordinate regulatory and compliance processes according to company and country requirements.
Ensure maintenance of existing registered product portfolio.
Ensure all systems are in place to meet all internal & external requirements.
Bachelor’s degree in Life Sciences from reputable universities, preferably in Chemical Engineering, Pharmacy, Chemistry, Biology or related fields,
Minimum 7+ years Regulatory experience preferably in innovative products,
Excellent planning and follow-up skills with a proactive approach
Excellent attention to details, motivated
Strong multitasking skills & operate in a fast-paced environment,
Excellent communication, problem solving and collaboration skills in relations with internal&external stakeholders
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint,
Advanced level in written and spoken English.
Travel: No
Job Type: Experienced
Schedule: Full-time

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