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About Abbott
Abbott 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 Abbott
At 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- GEM & Levant
This position works out of our UAE office in the Established Pharmaceutical division.
This is a fixed term contract role for 1 year.
About Established Pharmaceuticalsu2014We 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.
As Regulatory Affairs Senior Specialist, you'll be responsible for preparationandsubmissionofdossiersaccordingtocountryspecific requirements and regulations.
What you'll do-
Regulatory Affairs Coordination
Follow up on regulatory activities and plans for the assigned countries, renewal registration, registration, variation changes, safety updates, pricing, labelling and site transfers.
Responsibleforpreparationandsubmissionofdossiersaccordingtocountryspecific requirements and regulations.
Provideregulatorysupportfortenderbusiness.
Respondtoagencyquestionsanddevelops/coordinatesappropriateresponses.
Initiatethepricingdocumentsbasedoneachcountry'sneeds.
Develop and create newlabellingprintout according to country's regulations for our core products without any disruption of the existence of these products.
CommunicatetheupdatedpatientInformationLeaflet.
Review promotional materialsandsubmittotheagency incountries where MOH approvals are required.
Handle promotional material's submission in MOH UAE.
Interaction withhealthauthorities throughoutthe lifecycleof products.
Provideguidancetopeersandotherexternalpartners.
Coordinate regulatory organization processes withdifferent partnersin different countries.
Communicateefficientlywithallbusinesspartnersandemployees
Act as regulatoryrepresentativeon project teams and provide advice onspecific projectscontributingtothedevelopmentofprojectplansandtargetproduct profiles.
Support, backup, solve,challenge,negotiate,act,planandrestoreglobaland country specific regulations and information.
Re-challengetheHAandregulatoryresponsibleonthevariation'stoolsandlaws
Required Qualifications:
Bachelor's degree of Pharmacy
Year of experience: 2-5 years
Experience in Regulatory Affairs . Registration requirement knowledge, Communication skills and analytical mindset,
Arabic & English language
Follow 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 atwww.abbott.com, on Facebook atwww.facebook.com/Abbottand on Twitter @AbbottNews and @AbbottGlobal.
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Job ID: 143877609
