Regulatory Strategy Specialist: Global Submissions

Arcadis; Puurs; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Arcadis is seeking a Regulatory Strategist to interpret federal, state and international regulations as they apply to products, processes and procedures. You will manage product registration activities and collaborate with cross-functional teams across QA, supply, manufacturing and R&D.

You will author regulatory dossiers (CTD, BLA, NDA), liaise with regulatory bodies, respond to health authorities, and support lifecycle changes while working in a dynamic, global network.

Qualifications

• Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,…) required.
• Minimum 3 years of experience in the pharmaceutical sector with regulatory (authoring CTD, BLA, CMC) and quality knowledge.
• Scientific knowledge and strong writing/analytical skills for regulatory documentation.

Responsabilités

• Support regulatory submissions (CTD, BLA, NDA…) and inform site colleagues of regulatory requirements.
• Author dossiers and communicate with regulatory colleagues to resolve issues.
• Collaborate with cross-functional stakeholders to deliver high-quality CMC submissions and ensure compliance.
• Manage timely responses to health authorities arising from lifecycle submissions.
• Assess post-approval changes and author the impacted dossier sections.
• Contribute to project completion and manage own time to meet targets within a team.

Connaissances

Regulatory writing

Cross-functional collaboration

Regulatory submissions

Communication

Negotiation

Analytical skills

Project management

Formation

Master's degree in Life sciences

Description du poste

Arcadis is seeking a Regulatory Strategist to interpret federal, state and international regulations as they apply to products, processes and procedures. You will manage product registration activities and collaborate with cross-functional teams across QA, supply, manufacturing and R&D.

You will author regulatory dossiers (CTD, BLA, NDA), liaise with regulatory bodies, respond to health authorities, and support lifecycle changes while working in a dynamic, global network.