Regulatory Affairs Specialist At Johnson & Johnson| pharmacists Vacancies
Job Description:
The main task of a Regulatory Affairs Specialistis the Launching of Medical Device Products in Egypt & PTM Market in addition to facilitating the registration, importation of shipments and ensuring the absence of any regulatory issue due to missing documentation.
Duties & Responsibilities
Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in UAE or through J&J distributors when applicable
MOH meetings.
Clearance support to distributers.
Updating the regulatory tracking systems
Having the renewed certificates & re-registration licenses of expired ones on time.
Responding to Change Impact Assessments before due dates.
Doing Copy Review process for promotional materials on time upon request.
FSCA reporting to MOH Vigilance Department & close all open cases on time.
Lift all regulatory restrictions for products that can be shipped to Egypt & PTM Tender support to commercial teams & distributers
Main performance measures (Performance Goals)
Business partnering (Sales, Marketing)
Supply Chain
Health Authorities
Local Distributors
Global Regulatory Affairs
Qualifications
Experience Required
Education: Bachelor’s (B.Sc.) Degree of Pharmaceutical or Sciences
Experience; min. 2 years
Advantages:
Language: English - Arabic
Location: Egypt
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