Regulatory Affairs Senior Specialist - METAP & CIS

🏢 Abbott
📍 United Arab EmiratesFull-timeOn-site
📅 Posted: 4w ago🔄 Updated: 4w ago
CV%
✨ AI Summary
Abbott is seeking a Regulatory Affairs Senior Specialist for their Established Pharmaceuticals division in UAE. This role focuses on managing regulatory activities for the METAP & CIS regions, including registrations, renewals, variations, and safety updates. The specialist will prepare and submit dossiers, respond to agency questions, and provide regulatory guidance to internal and external partners. This is a fixed-term contract role for 1 year.
Required Skills
Finance, Legal & Governance
Regulatory Affairs
Soft Skills & Professional Competencies
Initiative
Other
Product labelling
🎁 Benefits & Perks
Career development with an international company, Abbott is recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies by Fortune. Abbott is recognized as one of the best big companies to work for and the best place to work for diversity, working mothers, female executives, and scientists.
Requirements
Bachelor's degree in Pharmacy with 3-5 years of experience in Regulatory Affairs within the pharmaceutical segment. Knowledge of registration requirements, communication skills, and an analytical mindset are essential. Proficiency in Arabic and English languages is required.
Description
About AbbottAbbott is a global healthcare leader that is creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow and learn, care for yourself and your family, be your true self, and live a full life. You will have access to :Career development with an international company where you can grow your dream career.A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies by Fortune.A company recognized as one of the best big companies to work for and the best place to work for diversity, working mothers, female executives, and scientists.The Opportunity - Regulatory Affairs Senior Specialist- METAP & CISThis position works out of our UAE office in the Established Pharmaceutical division.This is a fixed term contract role for 1 year.About Established Pharmaceuticals—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 covers multiple therapeutic areas, including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.What You'll Do- Follow up on regulatory activities and plans for the assigned countries, renewal registration, registration, variationchanges, safety updates, pricing, labelling and site transfers. Responsible for supporting preparation and submission of dossiers according to country specific requirements andregulations. Support to respond to agency questions and develops/coordinates appropriate responses. Support with product labelling related activities Provide guidance and regulatory inputs to peers and other external partners. Coordinate regulatory organization processes with different partners in different countries. Communicate efficiently with all business partners and employees Lead or support regulatory strategic initiatives. Act as regulatory representative on project teams and provideadvice on specific projects contributing to the development of project plans and target product profiles. Support, backup, solve, challenge, negotiate, act, plan and restore global and country specific regulations andinformation. Support with health authority external engagement activitiesRequired Qualifications :Bachelor's degree of PharmacyYear of experience : 3-5 years experience in Regulatory Affairs within pharmaceutical segment .Registration requirement knowledge,Communication skills and analytical mindsetArabic & English languageFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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🎯 Overalli74%
⚡ Skillsi85%
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Ontology Match: 85.0
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