Global Regulatory Affairs Lcm&e

**Global Regulatory Affairs LCM&E****Major Tasks**1) Responsibility for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions, BHC ProductSupply, Medical, Drug Safety and Marketing, to ensure early identification of major regulatory hurdles and issues with regard to CMC related topics, regulatory guidelines and legal requirements, and coordination of respective corrective actions. Provides active input into GRTs for assigned projects to ensure timely submission and first cycle approval.2) Responsibility for timely availability and final content of CMC IND/IMPD, NDA/MAA-, sNDA-, or BLA-submissions for assigned productsto Health Authorities, including responses to health authority questions.3) Responsibility for the CMC change management for assigned development and marketed products, which includes providing regulatory assessments, tracking of CMC changesand processing of requests for related documentation(evaluation, consolidation, prioritization and review), responsibility for coordination of responses to health authority questions, and for implementation of CMC changes after HA approvals with product supply, to ensure regulatory CMC compliance.4) Ensures adequate surveillance of the CMC-related regulatory environment for assigned products and anticipates and influences changes in this environment globally.5) Manages scientific support of assigned marketed products with respect to regulatory aspects and Labeling in close cooperation with the respective TA heads.6) Coordinates and ensures the timely generation of regulatory documents adhering to global, regional and local requirements.7) Responsibility for the support of assigned marketed products to ensure the successful maintenance of and life-cycle (variations, renewals or deficiency letter), ensuring regulatory guidelines are met.8) Manages the preparation of registration dossiers related to assigned products and proactively identifies and tracks regulatory activities and /or issues and risks and brings these to the attention of RA CC infrastructure management as necessary9) Coordinates the publishing and dispatching activities of the variations to the respective local regulatory affairs as well as submitting through EU gateway.**Skills**- Education - Ph.D., M.D., or PharmD degree in life sciences with a 2+ years of regulatory experience ; or MS with a 4+ years of Regulatory experience, or a Bachelor’s degree 6+ years’ of regulatory experience. - 2+ years of regulatory experience in Pharmaceutical Industry Competencies- Excellent oral and written communication skills.- Well developed management and leadership skills, as incumbent has to lead multidisciplinary teams. Demonstrated cross-functional communication, interpersonal, influence, and negotiation skills- Ability to focuson multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure. Job holder must be able to work focused and target oriented in a complex scientific / technical environment. -Ability to harmonize and reconcile competing objectives to achieve the overall objectives. - Thorough knowledge of company policies and procedures in maintenance**Período de aplicación**:24 Febrero al 10 Marzo**Código de referencia**:**División**:Consumer Health**Ubicación**:Mexico : Ciudad de México : Ciudad de México**Área funcional**:Registro Farmacéutico**Grado de posición**:VS 1.1**Tipo de empleo**:Permanente**Tiempo de trabajo**:Full Time