Regulatory Affairs Specialist – Regulatory Scientist

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Assist the Regulatory Lead in formulating and implementing cohesive global and/or regional regulatory strategies for designated programs throughout development and post-approval phases.

• Aid in the preparation of regulatory documents for submission to Health Authorities.

• Support various submissions, including iPSPs/PIPs, ODDs, Briefing Books, INDs/CTAs, BLA/MAAs, and sBLA/Variations.

• Lead or assist in collaboration with subject matter experts to ensure timely responses to inquiries from Regulatory Agencies while upholding consistency with the established regulatory strategy.

• Foster an understanding of the regulatory landscape, competitor intelligence, and therapeutic area dynamics, applying insights to regulatory strategies.

• Recognize and evaluate regulatory risks and contribute to the development of mitigation strategies.

• Serve as a backup or delegate for the Regulatory Lead within project teams or workstreams.

• Review clinical trial plans, protocols, and submission plans as necessary to guarantee regulatory alignment.

• Provide regulatory insights and follow-up for inspections, audits, litigation support, and product complaints.

• Assist in the enhancement and continuous improvement of regulatory submission processes.

⛳️ Requirements

• Bachelor's degree in a scientific or biomedical discipline.

• At least 3 years of experience in a clinical development setting, ideally within Regulatory Affairs.

• Capable of working independently and adapting quickly.

• Highly self-driven with a proactive approach.

• Exceptional interpersonal skills, with a proven ability to cultivate effective relationships with a diverse array of stakeholders.

• Strong leadership and critical-thinking capabilities, with a collaborative approach to problem-solving and decision-making.

• Sound judgment and the capacity to analyze situations and information, making decisions grounded in facts and evidence.

• Proven leadership within the context of designated responsibilities.

• Effective communication skills within teams, supported by management guidance.

• Outstanding organizational abilities and a keen attention to detail.

• Proficient in prioritizing tasks effectively in a fast-paced environment.

• Proactive and collaborative, with the ability to drive projects forward across teams.

• Familiarity with current global clinical trial regulations.

• Capable of summarizing content for focused and maintenance submissions and providing training to others on submissions.

• Flexible mindset, with the resilience to adjust to shifting priorities and regulatory strategies.

• Willingness to travel as business requirements dictate.

🏝️ Benefits

• Fully remote work arrangement