Regulatory Manager / Senior Regulatory Manager New Remote, Spain

buscojobs España; Guadalajara; A distancia; EUR 70,000 - 90,000; Jornada completa

Descripción de la vacante

A leading company is seeking a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and guidance for clinical trials. The role involves ensuring compliant regulatory submissions and coordinating with various stakeholders. Candidates can work remotely from several European countries.

Formación

• Minimum 5 years regulatory experience for Manager level, 7 years for Senior Manager.

Responsabilidades

• Providing regulatory guidance throughout the clinical development lifecycle.
• Compiling and reviewing applications to Regulatory Authorities.
• Leading regional or global projects and overseeing Regulatory Affairs Specialists.

Conocimientos

Regulatory Strategy

Compliance

Communication

Interpersonal Skills

Self-Motivation

Educación

Bachelor's degree in a scientific or healthcare discipline

Descripción del empleo

Regulatory Manager / Senior Regulatory Manager

Location: Remote, Spain

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to join our team. Candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland.

The Regulatory Manager provides regulatory strategy and development guidance for clinical trials, agency meetings, orphan designations, pediatric planning, and accelerated procedures. They ensure timely, well-organized, and compliant regulatory submissions. The Regulatory Manager coordinates and prepares documents for submission to Regulatory Authorities and Ethics Committees.

Key Responsibilities include:

1. Providing regulatory guidance throughout the clinical development lifecycle.
2. Compiling, coordinating, and reviewing applications to Regulatory Authorities, including CTA/IND, annual reports, amendments, scientific advice, orphan designations, pediatric planning, and marketing applications.
3. Developing and reviewing submission documents to ensure compliance with regulatory standards.
4. Representing Global Regulatory Affairs in project team meetings with internal and external stakeholders.
5. Leading regional or global projects and overseeing Regulatory Affairs Specialists to meet submission targets.
6. Maintaining project plans, trackers, and regulatory intelligence tools.
7. Supporting the development of Regulatory Affairs staff.
8. Contributing to regulatory strategy and timeline development for new studies.
9. Participating in corporate quality initiatives and staying updated on relevant laws and guidelines.
10. Providing ICH GCP guidance, advice, and training.
11. Representing Regulatory Affairs in business development meetings.

Qualifications:

• Bachelor's degree or equivalent in a scientific or healthcare discipline.
• Minimum 5 years regulatory experience for Manager level, 7 years for Senior Manager.

Preferred:

• Basic understanding of financial management.

Other Requirements:

• Experience working in a Clinical Research Organization and leading clinical submissions.
• Knowledge of drug development processes, regulatory milestones, and regional regulations (EU, US).
• Ability to interpret clinical and pre-clinical results for regulatory strategy.
• Willingness to travel domestically and internationally.
• Strong interpersonal and team skills.
• Professionalism, punctuality, and commitment to quality.
• Ability to manage multiple tasks in a fast-paced environment.
• Self-motivation and independent working skills.
• Effective communication skills in English, both verbal and written.

We invite you to learn more about our organization, dedicated to groundbreaking cancer therapies. We value our employees' contributions and foster a supportive environment.