Hybrid Global Regulatory Affairs Lead

RDSWorks; Rotterdam; Híbrido; EUR 80.000 - 110.000; Jornada completa

Descripción de la vacante

A leading Software-as-a-Service provider in Rotterdam seeks a Senior Regulatory Affairs Specialist for a full-time hybrid role. This position involves preparing regulatory documentation, ensuring compliance with international regulations, and providing strategic guidance. The ideal candidate should have a strong background in regulatory affairs and life sciences, excellent communication skills, and the ability to manage multiple projects efficiently. This role offers a flexible work environment with occasional travel for client meetings.

Formación

• Proficiency in preparing Regulatory Documentation and coordinating Regulatory Submissions.
• Thorough knowledge of Regulatory Compliance and Regulatory Requirements in global markets.
• Strong expertise in the field of Regulatory Affairs with the ability to provide strategic guidance and direction.
• Excellent organizational and analytical skills, with strong attention to detail.
• Experience working within a cross-functional or international team environment.
• Ability to manage multiple projects simultaneously with a results-oriented approach.
• Advanced communication and presentation abilities to collaborate effectively with clients and stakeholders.
• Relevant experience or background in life sciences, healthcare, pharmaceutical industries, or related fields.

Responsabilidades

• Prepare, review, and submit regulatory documentation.
• Ensure compliance with international regulatory requirements.
• Monitor updates to global regulations and provide strategic guidance.
• Collaborate cross-functionally to drive regulatory initiatives.
• Support clients in achieving compliance in different markets.

Conocimientos

Regulatory Documentation Preparation

Regulatory Compliance Knowledge

Strategic Guidance in Regulatory Affairs

Organizational Skills

Analytical Skills

Cross-Functional Team Collaboration

Project Management

Communication and Presentation Skills

Life Sciences Background

Educación

Bachelor's or advanced degree in Regulatory Affairs, Life Sciences, Pharmacy, or related discipline

Descripción del empleo

A leading Software-as-a-Service provider in Rotterdam seeks a Senior Regulatory Affairs Specialist for a full-time hybrid role. This position involves preparing regulatory documentation, ensuring compliance with international regulations, and providing strategic guidance. The ideal candidate should have a strong background in regulatory affairs and life sciences, excellent communication skills, and the ability to manage multiple projects efficiently. This role offers a flexible work environment with occasional travel for client meetings.