Regulatory Manager / Senior Regulatory Manager New Remote, Spain

Precisionscientia; Alicante; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading clinical research organization is seeking a Regulatory Manager to provide regulatory strategy and guidance for clinical trials. This remote role involves coordinating submissions to Regulatory Authorities and ensuring compliance throughout the clinical development lifecycle. Candidates with a Bachelor's degree and significant regulatory experience are encouraged to apply.

Formación

• At least 5 years of regulatory experience for Manager level; 7 years for Senior Manager.

Responsabilidades

• Providing regulatory guidance throughout the clinical development lifecycle.
• Compiling, coordinating, and reviewing applications to Regulatory Authorities.
• Overseeing Regulatory Affairs Specialists to meet submission targets.

Conocimientos

Regulatory Strategy

Communication

Interpersonal Skills

Educación

Bachelor's degree

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 role involves coordinating and preparing documents for submission to Regulatory Authorities and Ethics Committees.

Essential functions 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 meetings, orphan designations, pediatric planning, and marketing applications. Offering strategic regulatory input as needed.
3. Developing and reviewing documents for submission to Regulatory Authorities and Ethics Committees to ensure compliance.
4. Representing Global Regulatory Affairs in project team meetings with internal and external stakeholders.
5. Leading or participating in project teams regionally or globally.
6. Overseeing Regulatory Affairs Specialists to meet submission targets.
7. Maintaining project plans, trackers, and regulatory intelligence tools.
8. Assisting in the development of Regulatory Affairs staff.
9. Contributing to regulatory strategies and timelines for new studies.
10. Participating in corporate quality initiatives.
11. Staying updated on laws, regulations, and guidelines related to drug development.
12. Providing ICH GCP guidance and training.
13. Representing Regulatory Affairs in business development meetings.

Qualifications:

• Bachelor's degree or equivalent, preferably in a scientific or healthcare discipline.
• At least 5 years of regulatory experience for Manager level; 7 years for Senior Manager.

Preferred:

• Basic understanding of financial management.

Other requirements:

• Experience working for a Clinical Research Organization and leading clinical submissions.
• Knowledge of drug development process and regulatory activities in major regions (EU, US).
• Ability to interpret clinical and preclinical study results.
• Knowledge of clinical trial methodology.
• Willingness to travel domestically and internationally.
• Strong interpersonal and communication skills in English.
• Ability to manage multiple tasks in a fast-paced environment.

We invite you to learn more about our organization and our commitment to groundbreaking cancer therapies. We value our employees and encourage innovative ideas that foster positive change.

About Precision for Medicine:

We are a precision medicine Clinical Research Organization dedicated to advancing oncology and rare disease therapies through innovative clinical trial designs, expert teams, and advanced data analytics.

All data provided will be handled in accordance with our Privacy Policy. For CA applicants, please refer to our CA Privacy Notice.

We are an Equal Opportunity Employer and value diversity in our workforce. We accommodate individuals with disabilities upon request.

Beware of fraudulent job offers; our organization only extends offers after proper communication and interviews.