Regulatory Affairs Manager — EU & Global (Hybrid)

Regeneron Pharmaceuticals, Inc.; Amsterdam; Híbrido; EUR 85.000 - 125.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Regulatory Affairs to lead regulatory activities for EU and international markets in a hybrid Amsterdam setting. You will coordinate global teams across clinical, labeling, commercial, and quality functions, and shape regulatory strategies.

Candidates should have 3–4 years in biopharmaceutical regulatory affairs, strong project management, and experience with submissions and regulatory databases. Oncology/rare disease experience is a plus.

Formación

• Bachelor's or advanced degree in life sciences, pharmacy, or a related scientific discipline.
• 3–4 years biopharmaceutical regulatory affairs experience.
• Knowledge of regulatory requirements and proficiency with regulatory databases.
• Ability to manage parallel submissions against firm deadlines.

Responsabilidades

• Manage regulatory activities for assigned products across EU and international markets.
• Coordinate global teams, local entities, and partners across clinical, labeling, commercial, and quality functions.
• Communicate evolving regulatory strategies and insights across in-scope markets.
• Develop processes, user guides, work instructions, and standard operating procedures.
• Represent Regulatory Affairs in cross-functional forums and negotiate regulatory objectives.
• Support inspections and EU and UK Clinical Trial Applications when required.
• Ensure activities follow procedures and company standards.
• Foster effective matrix working while adapting to changing priorities.

Conocimientos

Regulatory affairs knowledge

Regulatory databases

Submissions management

Written communication

Project management

Matrix working

Cross-functional collaboration

Problem solving

Educación

Bachelor's or advanced degree in life sciences/pharmacy

Herramientas

Regulatory databases

Global submissions tools

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Regulatory Affairs to lead regulatory activities for EU and international markets in a hybrid Amsterdam setting. You will coordinate global teams across clinical, labeling, commercial, and quality functions, and shape regulatory strategies.

Candidates should have 3–4 years in biopharmaceutical regulatory affairs, strong project management, and experience with submissions and regulatory databases. Oncology/rare disease experience is a plus.