Global Regulatory Affairs Scientist: Submissions & Strategy

ThermoFisher Scientific; Brussel Hoofdstad; Sur place; EUR 75 000 - 110 000; Plein temps

Résumé du poste

Thermo Fisher Scientific is seeking a Regulatory Affairs Scientist to support global and regional regulatory strategies across development and post-approval programs. You will collaborate with Regulatory Leads, subject matter experts and cross-functional teams to ensure regulatory submissions align with requirements and strategy.

You’ll contribute to Health Authority interactions, risk assessments, and regulatory planning while expanding your expertise in the global regulatory landscape.

Qualifications

• University degree in a scientific or biomedical field.
• Minimum 3 years’ experience in a clinical development environment, preferably within Regulatory Affairs.

Responsabilités

• Support Regulatory Lead in developing and executing global/regional regulatory strategies for assigned programs.
• Contribute to 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 SMEs to provide timely responses to Regulatory Agency queries.
• Develop understanding of regulatory environment and apply insights to strategies.
• Identify and assess regulatory risks and contribute to mitigation strategies.
• Act as backup for the Regulatory Lead within teams to maintain alignment.
• Review clinical trial plans and submission plans for alignment with regulatory requirements.
• Provide regulatory input related to inspections, audits, and product complaints.
• Support development and improvement of processes related to regulatory submissions.

Connaissances

Independent learning

Interpersonal skills

Leadership

Critical thinking

Communication

Organizational skills

Prioritisation

Formation

Bachelor's degree in a scientific/biomedical field

Description du poste

Thermo Fisher Scientific is seeking a Regulatory Affairs Scientist to support global and regional regulatory strategies across development and post-approval programs. You will collaborate with Regulatory Leads, subject matter experts and cross-functional teams to ensure regulatory submissions align with requirements and strategy.

You’ll contribute to Health Authority interactions, risk assessments, and regulatory planning while expanding your expertise in the global regulatory landscape.