Spain-Based Senior Regulatory Affairs Manager

Jobgether; España; Presencial; EUR 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare

Flexible work

Descripción de la vacante

Jobgether, on behalf of a partner company, is seeking a Manager, Regulatory Affairs based in Spain to lead regulatory submissions across multiple markets within a dynamic clinical research environment.

You will oversee submissions, provide regulatory guidance, review IMPDs/IBs, coordinate with sponsors and project teams, and mentor junior staff while contributing to proposals and business development.

Formación

• Bachelor's degree in a relevant scientific discipline.
• Minimum 5-7 years in pharma or CRO with senior regulatory affairs or start-up experience.
• Strong leadership, planning, and cross-functional collaboration skills.
• Excellent written and spoken English communication.
• Ability to manage multiple priorities in a fast-paced environment.

Responsabilidades

• Lead regulatory submissions across EMEA, APAC, and LATAM with timely approvals.
• Provide expert regulatory guidance to sponsors and project teams.
• Review IMPDs, IBs, and study documents for ICH GCP alignment.
• Coordinate with Project Managers, CRAs, and Medical & Scientific Affairs.
• Mentor junior staff and contribute to bids, proposals, and feasibility.

Conocimientos

Regulatory affairs

Leadership

Project management

Clinical start-up

English communication

Educación

Bachelor's degree in life sciences

Descripción del empleo

Jobgether, on behalf of a partner company, is seeking a Manager, Regulatory Affairs based in Spain to lead regulatory submissions across multiple markets within a dynamic clinical research environment.

You will oversee submissions, provide regulatory guidance, review IMPDs/IBs, coordinate with sponsors and project teams, and mentor junior staff while contributing to proposals and business development.