Reg Affairs Manager - Global Ctas (Atmp/gmo)

JR Spain; Barcelona; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

JR Spain busca un Gerente de Asuntos Regulatorios basado en Barcelona. Este puesto ofrece la oportunidad de liderar estrategias regulatorias para ensayos clínicos en un entorno global. Se requiere un mínimo de 5 años de experiencia relevante, con enfoque en gestión de proyectos y habilidades interpersonales sólidas. Ofrecemos un salario competitivo y un entorno flexible que promueve un equilibrio entre trabajo y vida personal.

Servicios

Salario competitivo

Beneficios enfocados en la salud y el bienestar

Cultura de trabajo flexible

Formación

• Mínimo 5 años de experiencia en un rol relevante.
• Experiencia comprobada en gestión de proyectos y trato con clientes.
• Conocimiento de requisitos regulatorios globales/nacionales para ensayos clínicos.

Responsabilidades

• Dirigir la preparación de presentaciones regulatorias globales garantizando cumplimiento.
• Gestionar presupuestos de proyectos y previsiones.
• Participar en reuniones con clientes y agencias regulatorias.

Conocimientos

Comunicación en inglés

Gestión de proyectos

Atención al detalle

Habilidades interpersonales

Organización

Habilidades de negociación

Educación

Licenciatura o grado superior relacionado

Herramientas

MS Office

Descripción del empleo

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Reg Affairs Manager - Global Ctas (Atmp/gmo), Barcelona

Client: Thermo Fisher Scientific

Location: Barcelona, Spain

Job Category: Other

EU work permit required: Yes

Job Reference:

713019803985929830432460

Job Views:

1

Posted:

23.07.2025

Expiry Date:

06.09.2025

Job Description:

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with resources to achieve individual career goals while advancing science through research, development, and delivery of therapies. Our work spans laboratory, digital, and decentralized clinical trial services in over 100 countries, supporting health outcomes worldwide.

We are seeking a Regulatory Affairs Manager to join our global Regulatory Affairs department. This role offers the opportunity to develop your regulatory career in a global clinical trial setting. You will be part of a team providing innovative regulatory solutions, managing regulatory affairs responsibilities, and leading discussions with clients and regulatory agencies. Responsibilities include coordinating global regulatory strategies for clinical trials, providing strategic regulatory guidance, preparing client deliverables, and acting as a liaison with internal and external stakeholders. You will also support business development, lead initiatives, and contribute to quality improvement efforts.

Responsibilities:

• Lead the preparation of global regulatory submissions, ensuring compliance with local and regional standards.
• Provide updates on legislation and guidance to internal clients.
• Manage project budgets and forecasts.
• Identify out-of-scope activities and coordinate contract modifications.
• Assist in business development through client presentations and proposal development.
• Provide leadership, training, and guidance to junior team members.
• Ensure compliance with SOPs and WPDs.
• Participate in meetings with clients and regulatory agencies.

Qualifications:

• Bachelor's or higher degree, or equivalent, with relevant academic or vocational qualifications.
• At least 5 years of relevant experience.
• Proven project management and client-facing experience.

Knowledge, Skills, and Abilities:

• Excellent English communication skills; proficiency in local language if applicable.
• Experience with ATMP/GMO.
• Attention to detail and quality, with strong editorial skills.
• Interpersonal skills for effective teamwork and liaison roles.
• Advanced computer skills, including MS Office and adaptability to new technologies.
• Strong organizational and planning skills.
• Negotiation skills.
• Ability to work independently and exercise judgment.
• Deep understanding of global/regional/national regulatory requirements for clinical trials, including ICH guidelines.
• Analytical and problem-solving skills.
• Experience with budgeting and forecasting.

What we offer: Competitive salary, extensive benefits focused on health and well-being, flexible working culture promoting work-life balance.