Regulatory Affairs Manager | (A-762)

G&L Scientific; Guadalajara; Presencial; EUR 45.000 - 70.000; Jornada completa

Descripción de la vacante

Una empresa líder en ciencias de la salud busca un Regulatory Affairs Manager con más de 7 años de experiencia. En este rol, contribuirás a la estrategia regulatoria y asegurarás la conformidad a lo largo del ciclo de vida de los productos, trabajando con diversas autoridades competentes. Ofrecemos un contrato permanente, salarios competitivos y un paquete de beneficios atractivo, así como un entorno de trabajo flexible con proyectos variados.

Servicios

Seguro médico

Seguro por discapacidad

Plan de pensiones

Remuneración flexible

Horario laboral flexible

Formación

• Experiencia mínima de 7 años en asuntos regulatorios, preferiblemente en una empresa farmacéutica.
• Fluidez en inglés y español.

Responsabilidades

• Desarrollar y ejecutar estrategias regulatorias para la inscripción de productos.
• Preparar documentación CMC y asegurar el cumplimiento de normativas.

Conocimientos

Organización

Comunicación

Atención al detalle

Resolución de problemas

Habilidades analíticas

Educación

Grado o máster 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:

- Developing and executing a regulatory strategy to support the registration of products in line with applicable regulatory requirements.
- Preparing, developing and analyzing CMC documentation for Module 3, quality summaries and safety and efficacy documentation.
- Working on safety, efficacy and CMC variations: variation typification and documentation preparation.
- Supporting R&D;, manufacturing,



quality control and quality assurance departments for potential queries.
- Submitting regulatory documentation to authorities ensuring compliance with the regulatory standards.
- Planning and managing regulatory procedures on behalf of client companies.
- Ensuring ongoing compliance of products throughout their lifecycle by monitoring regulatory changes and assessing potential impacts.
- Managing the authorisation according to national and EU regulations (MRP, DCP and centralized procedures).
- Ensuring all project work aligns with current regulatory guidance and meets internal standards.

Background:

Bachelors or masters degree in health science.

Experience:

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




- 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 degree of 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 working 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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https://www.kitempleo.es/empleo/200811492/regulatory-affairs-manager-a-762-guadalajara/?utm_source=html

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