Senior Regulatory Affairs Associate

Proclinical Staffing; England; Remote; GBP 50,000 - 70,000; Full time

Job summary

Proclinical Staffing recherche un Senior Regulatory Affairs Associate pour soutenir les lancements de produits en Europe et au Moyen-Orient. Ce rôle implique la collaboration avec différentes équipes et la gestion des exigences réglementaires tout au long du cycle de vie du produit. Le candidat idéal aura un diplôme en sciences, une connaissance des exigences réglementaires européennes et une forte capacité d'analyse.

Qualifications

• Expérience avec les exigences réglementaires européennes.
• Familiarité avec les pratiques des entreprises de grande et petite taille.
• Capacité à travailler dans un environnement dynamique.

Responsibilities

• Soutenir les lancements de produits dans des régions spécifiques.
• Collaborer avec l'équipe supply chain et qualité.
• Préparer et livrer des soumissions pour la gestion du cycle de vie des produits.

Skills

Analyse

Résolution de problèmes

Communication

Travail en équipe

Education

Diplôme en sciences ou domaine connexe

Diplôme avancé préféré

Job description

Are you ready to embrace the flexibility of remote work and drive innovation, collaboration, and growth-no matter where you are?

Proclinical is seeking a Senior Regulatory Affairs Associate to support product launches across Europe, Central Eastern Europe, and the Middle East. You will collaborate with supply chain and quality assurance teams to navigate country-specific regulatory requirements and risks. Your role involves working closely with commercial, medical teams, and external partners to ensure business objectives are met. This position requires you to contribute to application preparations and submissions throughout the product lifecycle, including marketing authorizations, variations, and renewals. Additionally, you will assist in implementing a Regulatory Information Management system to track regulatory activities effectively.

Responsibilities:

• Support product launches in specified regions.
• Collaborate with supply chain and quality assurance to identify regulatory requirements and risks.
• Partner with commercial and medical teams, and external regulatory partners.
• Maintain relationships with distribution partners and consultancies.
• Prepare and deliver submissions for product lifecycle management.
• Contribute to new regulatory guidance preparation and communicate impacts.
• Assist in implementing a Regulatory Information Management system.

Key Skills and Requirements:

• Degree in Science or related field; advanced degree preferred.
• Knowledge of European regulatory requirements for innovative products.
• Experience with large and small company practices.
• Familiarity with European Regulatory Affairs and National Competent Authorities.
• Ability to work in a fast-paced, high-visibility environment.
• Strong analytical, problem-solving, and communication skills.
• Team player with initiative and ownership.
• Results-focused, adaptable, and self-motivated.
• Comfortable in a multicultural environment.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at [e-mail].

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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