Regulatory Affairs Senior Specialist-GEM & Levant (Fixed term contract)

About AbbottAbbott is a global healthcare leader that is creating breakthrough science to improve peoples health. Were 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- GEM & LevantThis position works out of our UAE office in the Established Pharmaceutical division.This is a fixed term contract role for 1 year.About Established PharmaceuticalsWe are committed to bringing the benefits of our trusted medicines to more people in the worlds fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines covers multiple therapeutic areas including gastroenterology womens health cardiometabolic pain management/central nervous system and respiratory.As Regulatory Affairs Senior Specialist youll be responsible for preparationandsubmissionof dossiersaccordingto countryspecific requirements and regulations.What you'll doRegulatory Affairs CoordinationFollow up on regulatory activities and plans for the assigned countries renewal registration registration variation changes safety updates pricing labelling and site transfers.Responsibleforpreparationandsubmissionof dossiersaccordingto countryspecific requirements and regulations.Provideregulatorysupportfor tenderbusiness.Respondtoagencyquestionsanddevelops/coordinatesappropriateresponses.Initiatethepricing documentsbasedoneachcountrysneeds.Develop and create newlabellingprintout according to countrys 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 materials submission in MOH UAE.Interaction withhealthauthorities throughoutthe lifecycleof products.Provideguidance topeersandotherexternalpartners.Coordinate regulatory organization processes withdifferent partnersin different countries.CommunicateefficientlywithallbusinesspartnersandemployeesAct as regulatoryrepresentativeon project teams and provide advice onspecific projectscontributingtothedevelopmentofprojectplansandtargetproduct profiles.Support backup solvechallenge negotiateactplanandrestoreglobaland country specific regulations and information.Re-challengetheHAandregulatory responsibleonthevariationstoolsandlawsRequired QualificationsBachelors degree of PharmacyYear of experience: 2-5 yearsExperience in Regulatory Affairs . Registration requirement knowledge Communication skills and analytical mindsetArabic & English languageAbbott is an Equal Opportunity Employer committed to employee diversity.The base pay for this position is N/AIn specific locations the pay range may vary from the range posted.JOB FAMILY: Regulatory OperationsDIVISION: EPD Established PharmaLOCATION: United Arab Emirates > Dubai : Dubai Airport Freezone Building 5WA Floor 8ADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Not specifiedMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Not ApplicableRequired Experience: Senior IC#J-18808-Ljbffr