Regulatory Affairs Analyst

Job PurposeAct as responsible for obtaining and maintaining Theramex product registrations and licenses in compliance with COFEPRIS regulations. Collaborate with our headquarters and coordinate third parties related to regulatory affairs.Key Duties and ResponsibilitiesPrepare, review and submit registration for new products (focus on synthetics and biologicals)Prepare, review and submit post-registrations and changesManage product lifecycleBe aware of national legislation and its updatesReview and approve promotional materialsReview and approve package materialsMinimum Requirements (Experience & Education)Pharmacy degreeAt least 3 years of professional experience with drug registration and post-registrationAdvanced EnglishReliability, responsibility, organization, commitment, flexibility, proactivitySolid knowledge in evaluating technical documentation for the preparation of registration dossiers, creation, and submission of registration and post-registration processes toCOFEPRIS#J-18808-Ljbffr