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Regulatory Affairs

2 months ago

Manila, National Capital Region, Philippines Manpower Philippines Full time
An academic degree on health sciences, life sciences, regulatory affairs (eg. Physician, Pharmacist, Veterinarian or Scientific background, as applicable based on countries' jurisdiction.Minimum of 2 years' experience from the pharmaceutical or healthcare sectorExperience in regulatory affairs, excellent writing and presentation skillsStrong knowledge of regulatory requirements for variations, renewal and labeling of countries under his/her responsibility.Good level of spoken and written English. Addition of local language in based country may be an advantage.Job scope:Preparation and elaboration of "ready to submit/use" dossier for new registration*, tenders*, site registration/renewals*, post approval changes (administrative, CMC, labeling, etc.) and renewals in order to comply with region strategic plan and the maintenance of the marketing authorizations for the products already in the market for the countries of responsibility.