Regulatory Affairs Specialist – Regulatory Scientist

🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Support the Regulatory Lead in developing and executing integrated global and/or regional regulatory strategies for assigned programs across development and post-approval maintenance. • Contribute to compiling regulatory documents for submission to Health Authorities. • Support submissions including iPSPs/PIPs, ODDs, Briefing Books, INDs/CTAs, BLA/MAAs and sBLA/Variations. • Lead or support collaboration with subject matter experts to provide timely responses to Regulatory Agency queries while maintaining consistency with the agreed regulatory strategy. • Develop understanding of the regulatory environment, competitor intelligence and therapeutic area landscape, and apply insights to regulatory strategies. • Identify and assess regulatory risks and contribute to mitigation strategies. • Act as backup or delegate for the Regulatory Lead within project teams or workstreams. • Review clinical trial plans, protocols and submission plans where applicable to ensure regulatory alignment. • Provide regulatory input and follow-up for inspections, audits, litigation support and product complaints. • Support development and continuous improvement of regulatory submission processes.

🎯 Requirements

• University degree in a scientific or biomedical field. • Minimum 3 years’ experience in a clinical development environment, preferably within Regulatory Affairs. • Independent and able to learn quickly. • Highly self-motivated with a hands-on approach. • Excellent interpersonal skills, with the ability to build effective relationships across a diverse range of stakeholders. • Strong leadership and critical-thinking skills, with the ability to work collaboratively to solve problems and make decisions. • Sound judgement and the ability to analyse situations and information, making decisions based on facts and evidence. • Demonstrated leadership within the context of assigned responsibilities. • Able to communicate effectively within teams, with guidance and support from management. • Excellent organisational skills and strong attention to detail. • Able to prioritise effectively within a fast-paced environment. • Proactive and collaborative, with the ability to drive assignments forward across teams. • Working knowledge of current global clinical trial regulations. • Able to summarise content for focused and maintenance submissions and provide training to others on submissions. • Flexible mindset, with the resilience to adapt to changing priorities and regulatory strategies. • Able to travel based on business needs.

🏖️ Benefits

• Fully remote work arrangement