Regulatory Affairs Specialist

Arcadis; Puurs; Sur place; EUR 65 000 - 95 000; Plein temps

Résumé du poste

Arcadis in Belgium seeks a Regulatory Strategist to interpret federal, state and international regulations as applied to products, processes and procedures. You will manage product registration activities and report to the Lead Regulatory.

You will collaborate with R&D, global regulatory colleagues and cross-functional teams to support new product introductions and lifecycle management across markets. Fluent English is required, and strong writing skills are essential.

Qualifications

• Master's degree in Life sciences or related field.
• Minimum 3 years of experience in the pharmaceutical sector with regulatory writing.
• Experience with CTD, BLA, NDA and CMC.
• Knowledge of EMA and FDA guidelines.

Responsabilités

• Support regulatory submissions (CTD/BLA/NDA) by informing site colleagues of regulatory requirements and by drafting dossiers.
• Liaise with regulatory colleagues to communicate and resolve potential issues.
• Collaborate across the network of stakeholders to deliver high quality CMC submissions and ensure compliance.
• Manage timely responses to Board of Health requests from lifecycle submissions.
• Assess post-approval changes at the manufacturing site and author the impacted sections of the dossier.
• Contribute to project completion, manage time to meet targets, and develop plans for work activities within a team.

Connaissances

Regulatory submissions

Regulatory writing

Cross-functional teams

CTD/BLA/NDA

English fluency

Regulatory guidance

Pharma industry experience

Formation

Master 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 dossier
• Liaise with regulatory colleagues to communicate and resolve potential issues
• Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance
• Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility
• Assess Post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier
• Contribute 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 quality
• Scientific 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