Regulatory Affairs Specialist

ppSelect how often (in days) to receive an alert: /ph3Job Title: Regulatory Affairs Specialist /h3pJob Requisitions No.: 18302 /ph3Job Description: /h3h3Role Details /h3pThe role has primary responsibility for supporting all local regulatory affairs workflow including preparation of dossiers and applications for new registration and maintain existing products life-cycle as well as applying the pharmacovigilance policy under the supervision by line Manager. /ph3The Role /h3pSupport RA and QA team in: /pulliPreparation of dossiers and applications to register new products and maintain existing products life- cycle /liliPreparation of parallel import applications for national and central import procedures. /liliSupporting the relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications. /liliSubmission of Life Cycle Management changes (variations, marketing status, sunset clause, renewals and line extensions) /liliArtwork revision process, i.e. requesting, proof reading, approval and implementation of artwork /liliClose cooperation with supply chain and marketing department to ensure product launch and marketing materials approval from regulatory perspective. /li /ulh3The Person /h3ulliAt least 6 months 1 -year professional experience on similar position or internship in RA Department in pharmaceutical company or national competent authority /liliKnowledge of pharmaceutical law and the required documentation for pharmaceutical product /li /ulh3The Rewards /h3h3A Bit About Us /h3h3Footer /h3pAll applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability. /ppRequisition ID: ((id)) /p /p #J-18808-Ljbffr