Regulatory Affairs Manager | (QP-757)

G&L Scientific; Huesca; Presencial; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

Una empresa líder en el sector científico busca un Regulatory Affairs Manager con experiencia sólida para garantizar que los clientes cumplen con las regulaciones. El candidato ideal tendrá un fuerte enfoque organizativo y comunicativo, y será responsable de la preparación y ejecución de estrategias regulatorias, así como de la gestión de la documentación necesaria ante las autoridades. Este rol ofrece un contrato permanente, salarios competitivos y un paquete de beneficios atractivo en un ambiente dinámico.

Servicios

Contrato permanente

Salarios competitivos

Paquete de beneficios (seguros médicos y de discapacidad, plan de pensiones)

Horario de trabajo flexible

Variedad de proyectos y desafíos

Formación

• 7+ años de experiencia en asuntos regulatorios en la industria farmacéutica.
• Experiencia en preparación de documentación para la regulación de productos.
• Fluidez en inglés y español, con capacidad de gestión de múltiples proyectos.

Responsabilidades

• Desarrollar y ejecutar estrategias regulatorias para registros de productos.
• Gestionar la documentación de CMC y asegurar el cumplimiento regulatorio.
• Trabajar con diferentes autoridades competentes y gestionar variaciones de seguridad.

Conocimientos

Organización

Comunicación

Atención al detalle

Resolución de problemas

Análisis

Adaptabilidad

Educación

Título universitario en ciencias de la salud

Herramientas

MS Office

Descripción del empleo

Are you an experienced Regulatory Affairs professional? Join our team as a Regulatory Affairs Manager and play a vital role within G&L; Scientific team. This role focuses on cross-functional activities, managing documentation and ensuring compliance with regulatory and legal requirements.

Responsibilities may include:

1. Developing and executing a regulatory strategy to support the registration of products in line with applicable regulatory requirements.
2. Preparing, developing and analyzing CMC documentation for Module 3, quality summaries and safety and efficacy documentation.
3. Working on safety, efficacy and CMC variations: variation typification and documentation preparation.
4. Supporting R&D, manufacturing, quality control and quality assurance departments for potential queries.
5. Submitting regulatory documentation to authorities ensuring compliance with the regulatory standards.
6. Planning and managing regulatory procedures on behalf of client companies.
7. Ensuring ongoing compliance of products throughout their lifecycle by monitoring regulatory changes and assessing potential impacts.
8. Managing the authorization according to national and EU regulations (MRP, DCP and centralized procedures).
9. Ensuring all project work aligns with current regulatory guidance and meets internal standards.

Background:

Bachelor's or master's degree in health science.

Experience:

• 7+ years in regulatory affairs, with at least 3 years of experience in a pharmaceutical company.
• Familiarity with European e-submission portals.
• Practical experience working with different National Competent Authorities (NCAs).
• Experience with small and large molecules, ideally across multiple therapy areas/dosage forms.
• Experience in writing and reviewing module 3, module 4 and module 5 documentation.

Experience in biological products would be a bonus.

Skills & Competencies:

• Strong organizational and communication skills with the ability to manage multiple projects.
• Proactive and team-oriented mindset with a commitment to continuous learning.
• Excellent working knowledge of MS Office.
• Fluent written and spoken English and Spanish.
• High attention to detail and troubleshooting skills. Analytical skills and ability to summarize.
• Flexible and adaptable, with innovative problem-solving abilities.
• Expert in interpreting regulatory requirements and determining compliance strategies.

Why work at G&L; Scientific?

• Permanent contract.
• Competitive salaries.
• Benefits package (medical insurance, disability insurance, pension plan, and flexible remuneration).
• Flexible working schedule.
• Wide variety of projects, new challenges, and experiences.

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