Senior Regulatory Affairs Specialist

RDSWorks; Rotterdam; Hybrid; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

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

Education

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

Tools

None

Job description

RDSWorks is a leading Software-as-a-Service (SaaS) platform designed to streamline regulatory projects through intelligent workflows, advanced data cross-referencing, and proactive risk management. By centralizing regulatory intelligence, our system monitors global regulatory changes from institutions like the FDA, ensuring clients remain compliant and prepared. Headquartered in Rotterdam, RDSWorks provides tailored solutions to simplify the complexities of global regulatory requirements. Our platform combines cutting-edge technology, expert insights, and a global scope to help organizations achieve operational excellence and regulatory confidence.

Role Description

The Senior Regulatory Affairs Specialist is a full-time hybrid role based in Rotterdam, with the flexibility to work partially from home. The role involves preparing, reviewing, and submitting regulatory documentation, ensuring compliance with international regulatory requirements. Responsibilities include monitoring updates to global regulations, providing strategic guidance on regulatory affairs, maintaining up-to-date knowledge of industry standards, collaborating cross-functionally to drive regulatory initiatives, and supporting clients in achieving compliance across different markets. Travel may be required occasionally for business purposes or client meetings.

Qualifications

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