Regulatory Affairs Specialist

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

As a Regulatory Strategist, you will be part of a team that will interpret federal, state and international regulations as they apply to products, processes, practices and procedures. In this role you will be responsible for product registration activities of the assigned products and will report to the Lead Regulatory. You will work in cross-functional teams with different departments (manufacturing, labs, QA, supply,…) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC) in order to support the introduction of new products.
Scope of work:Support regulatory submissions (CTD, BLA, NDA,…) of the products by informing site colleagues of regulatory requirements and by authoring the dossierLiaise with regulatory colleagues to communicate and resolve potential issuesCollaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring complianceManage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibilityAssess Post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossierContribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals
Experience:Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)Minimum 3 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA, CMC) and qualityScientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentationKnowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA)Ability to communicate effectively verbally and in writing, good negotiation and influencing skillsDynamic, flexible, enthusiastic and eager to learnAbility to work under minimal supervision and in a teamFluent in written and spoken English