Regulatory Affairs Senior Specialist-GEM & Levant
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Job Summary
About Abbott
Abbott 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 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 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 youll 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.
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.
Communicateefficientlywithallbusinesspartnersandemployees
Act as regulatoryrepresentativeon project teams and provide advice onspecific projectscontributingtothedevelopmentofprojectplansandtargetproduct profiles.
Support backup solvechallenge negotiateactplanandrestoreglobaland country specific regulations and information.
Re-challengetheHAandregulatory responsibleonthevariationstoolsandlaws
Required Qualifications:
Bachelors 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 on Facebook on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
Required Experience:
Senior IC
Key Skills
- Athletics
- Corporate Banking
- Dreamweaver
- Facilities
- IT Support
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
