Manager/Senior Manager Regulatory Affairs

Thermo Fisher Scientific Inc.; Ciudad de México; Presencial; MXN 30,000 - 90,000; Jornada completa

Descripción de la vacante

Una empresa innovadora busca un Senior Manager en Regulación para liderar estrategias regulatorias en el ciclo de vida de productos farmacéuticos. Esta posición implica trabajar con equipos globales para desarrollar y ejecutar estrategias regulatorias, coordinar presentaciones y evaluar riesgos regulatorios. Se requiere un candidato con experiencia en la industria farmacéutica y un sólido conocimiento de las regulaciones de EE. UU. y UE. Si tienes pasión por la regulación y deseas marcar la diferencia en el desarrollo de productos, esta es la oportunidad ideal para ti.

Formación

• 5+ años de experiencia en la industria farmacéutica, preferiblemente en países de LATAM.
• Experiencia en autoría de documentos regulatorios y presentaciones.

Responsabilidades

• Desarrollar y ejecutar estrategias regulatorias a lo largo del ciclo de vida del producto.
• Coordinar y contribuir al contenido de presentaciones regulatorias.

Conocimientos

Comunicación escrita y oral en inglés y español

Conocimiento de regulaciones de EE. UU. y UE

Organización y priorización de carga de trabajo

Estrategia regulatoria

Conocimiento de procedimientos y legislación regulatoria

Educación

Licenciatura en disciplina científica/ingeniería/salud

Maestría, PharmD o PhD

Herramientas

Formato CTD

Descripción del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Here’s What You’ll Do:

• Works with global regulatory lead(s), regulatory strategists, Global Regulatory Sub-Teams and project teams regarding the development and execution of regulatory strategy through the product development lifecycle.
• Coordinate, develop and contribute to content and format of regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, pediatric plans, DSURs, MAA/BLA/NDA, etc.
• Identify and assess regulatory risks for assigned projects or programs.
• Senior Manager may serve as point of contact with regulatory agencies relevant to assigned projects or programs, as appropriate.
• Ability to work both independently and within project teams, committees, etc. to achieve group goals.
• Accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from Health Agencies

Here’s What You’ll Bring to the Table:

• BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.
• 5+ years of experience in the Pharmaceutical industry preferred in LATAM Countries.
• 3+ years of experience in Regulatory strategy or relevant training/experience preferred
• Experience in Infectious Diseases and/or Biologicals is preferred
• Strong knowledge of current US and EU regulations
• Strong experience with CTD format and content of regulatory filings
• Exceptional written and oral communication in English and Spanish.
• Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EU
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
• Experience in authoring regulatory documents
• Knowledge and understanding of applicable regulations.
• Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.