- Proposes regulatory strategy and timelines for initial and amendment submissions to Competent Authority (CA) and Ethics Committee(s) (ECs) in the assigned countries and/or projects with supervision of more senior regulatory staff- As Regulatory Lead, provides leadership on regulatory submission in assigned projects - Prepares and adapt specific regulatory documents and submission packages according to local, EU and/or international requirements, guidelines and laws in the assigned country(ies) and/or projects- Ensures deliverables are on time and with quality- Reviews of submission packages of assigned country(ies) and/or projects before submission to CA and EC- As Regulatory Lead in assigned projects, acts as the main point of contact for clients for all aspects related to clinical study registration to CAs and ECs throughout the study lifecycle- Proactively communicates with assigned team members across relevant functions in order to drive project success- ldentifies project and/or country speciflc problems and risks related to clinical study applications and amendments and works with internal and external team members to provide and implement solutions, with close supervision of the Functional Area Lead- Supports development of country regulatory intelligence data related to clinical study application and amendment submissions to CAs and ECs- Maintains in-depth knowledge on regulatory requirements for assigned country(ies) and EU requirements, laws and regulations by regularly monitoring relevant resources and websites. Communicates relevant updates to the team- Keeps regulatory department trackers and the relevant project level reporting tool up to date- May participate in Kick-off meetings, audits and other project related meetings according to company / client needs- Participates in internal and external teleconferences meetings- Provides mentoring to more junior staff

- Management of activities and preparation of country submissions packs (initial and amendments/notifications) to RA, EC and other applicable local bodies according to local requirements to obtain allnecessary authorisations/approvals.- Preparation of Clinical Trial Application Forms (CountryEudraCT form and/or National Application Form).- Ensuring that IP labels are in adherence to country requirements and submitted where applicable. - Management of the country level Informed Consent and any other documentation given to patients (diaries, questionnaires) through to submission and approval by country level RA and EC as appropriate. -Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF, Veeva, PSO and other applicable PRA and Sponsor systems. - Perform role of Local Reviewer in the QC process

- Provide administrative and meeting support as needed.- Support with submissions, translations, maintains documentation, databases updates, when required.- Receives and distributes incoming mailing, including courier services.- Organizes and prioritizes large volumes of information.

- Register and evaluation of feasibility of new products.- Maintenance of portfolio: changes post-registration, renewals, upgrades PSUR's (Reports Periodic Safety) and all the steps that are required.- Intervene in the development process of packing material, revisions, corrections and approvals (boxes, labels, inserts), ensuring that they comply with existing legislation and texts adapted. - Conduct regular meetings with RA Latam (Brazil, Chile, Ecuador, Guatemala, Colombia, México) Latam to maintain the registration of new products and products approved and keep updated on Dashboard of the Consumer Health line. - Develop regulatory strategies and support the business to guarantee the commercialization of products, working hand to hand with management team and subsidiaries in Colombia, Germany, Mexico and Spain.- Direct report: Head of Regulatory Affairs CH Americas and Business Unit Director of Consumer Health Venezuela- Registro y evaluación de factibilidad de nuevos productos. - Mantenimiento del portafolio existente: Cambios post-registro, renovaciones, actualizaciones de PSUR’s y todas las gestiones que se requieran.- Intervenir en el proceso de desarrollo de material de empaque, realizando las revisiones, correcciones y aprobaciones (estuches, etiquetas, insertos).- Realizar reuniones periódicas con RA Latinoamérica (Brasil, Chile, Ecuador, Guatemala, Colombia, México,) para mantener documentado el proceso de registro de los nuevos productos y productos aprobados así como también mantener actualizado el Dashboard de la línea Consumer Health. - Desarrollar estrategias regulatorias y dar soporte al negocio a fin de garantizar la comercialización del medicamento, trabajando en conjunto con el equipo gerencial y las filiales en Alemania, Colombia, México y España. - Reporte directo de resultados: Gerente regional de RA Latinoamérica y Director de la unidad de negocio Consumer Health Venezuela.

- Assessment and development of dossiers received from parent.- Maintenance of dossiers: changes post-registration and renewals.- Support review of arts.- Support related regulatory departments to provide them with all the information necessary to ensure the marketing authorization.- Evaluación y elaboración de los dossiers recibidos desde casa matriz.- Mantenimiento de los productos registrados: Cambios post-registro y renovaciones.- Soporte en la revisión de artes de empaque, estuche y etiqueta.- Apoyar a departamentos afines a regulatorio a fin de facilitarles toda la información necesaria para garantizar la comercialización del medicamento.

- Handling, creating, updating and controlling of SOP’s, instructions, manuals, and equipment qualification protocols. - Update, review and creation of analytical techniques of products and raw materials.- Compliance with GLP. - Intermediate level of SAP management system (quality plans and views, hours of quality recipes planning, etc.), control inventories and controlled reagents.- Manejo, creación, actualización y control de procedimientos operativos estándar, instructivos de trabajo, instructivos de manejo y limpieza de equipos, y protocolos de calificación de equipos.- Actualización, revisión y creación de técnicas analíticas de materias primas y producto terminado.- Aseguramiento del cumplimiento en BPL. - Manejo intermedio del sistema SAP (planes y vistas de calidad, horas de calidad, recetas de planificación, etc.), inventarios y control de reactivos controlados

- Physical-chemical analysis of products and raw materials through HPLC, Spectrophotometry UV, titration, separation of mixtures, Karl Fisher water determination and dissolution.- Support in Microbiological analysis: Analysis of water for pharmaceutical use, analysis of non-sterile products, Sterility test and environmental controls. - Análisis Fisicoquímico de productos semiterminados y materias primas, A través de HPLC, espectrofotometría UV, titulación, separación de mezcla, determinación de humedad por Karl Fisher y disolución.- Soporte al laboratorio de Análisis Microbiológico: Análisis de agua para uso farmacéutico, análisis de productos no estériles, test de esterilidad y controles ambientales