Regulatory Project Manager – FSP

This is a fully remote position, open to applicants in Belgium, +3 more countries.

📋 Description

• Oversee regulatory activities for product lines including medical devices, pharmaceuticals, biologics, and in-vitro diagnostics.

• Formulate and execute regulatory strategies that support product development, registration, and lifecycle management.

• Provide strategic guidance on regulatory matters.

• Lead preparations for regulatory submissions.

• Engage with regulatory authorities effectively.

• Oversee regulatory intelligence initiatives.

• Collaborate with Quality, R&D, Marketing, and other stakeholders during product development and commercialization phases.

• Ensure compliance with regulatory requirements and promote regulatory excellence across the organization.

• Manage and mentor regulatory affairs personnel.

• Handle multiple regulatory projects concurrently.

⛳️ Requirements

• An advanced degree with 6 years of experience, or a Bachelor's degree with 8 years of experience in regulatory affairs within the pharmaceutical, medical device, or diagnostics sector.

• Preferred academic backgrounds include Life Sciences, Chemistry, Engineering, Pharmacy, or a related scientific discipline.

• Regulatory affairs certifications are advantageous.

• In-depth understanding of global regulations and guidelines (FDA, EMA, PMDA, NMPA).

• Proven expertise in developing and implementing regulatory strategies.

• Extensive experience with regulatory submissions (IND, BLA, NDA, 510(k), CE marking).

• A history of successful interactions with regulatory authorities.

• Experience in managing and developing regulatory affairs teams.

• Advanced knowledge of GMP/QMS requirements and compliance.

• Outstanding project management and organizational abilities.

• Strong analytical and problem-solving skills.

• Excellent written and verbal communication abilities.

• Capacity to influence and collaborate across various organizational levels.

• Proficiency in regulatory information management systems.

• Proven capability to manage multiple projects simultaneously.

• Willingness to travel approximately 20% of the time.

• Business-level proficiency in English is required; additional languages are a plus.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.