パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Senior Regulatory Affairs Associate (CTA & MAA)
応募 求人ID R0000045984 ロケーション プラハ, Hlavní město Praha 仕事内容We are looking for an experienced Senior Regulatory Affairs Associate to support both Clinical Trial Applications (CTAs) and Marketing Authorisation Applications (MAA) activities within the Czech Republic and broader EU regulatory environment.
In this role, you will have a chance to work on submissions for Parexel as well as dedicated for clients. Under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the business and the client. We will provide you with support of more senior staff to accomplish more complex tasks. You may act in a client-facing role with clear guidance and support from line management.
The role can be homne or offic ebasd in Prague.
Key responsibilities:
Preparation, submission and maintenance of Clinical Trial Applications (CTAs) acting as Local Regulatory Contact (LRC) and/or Regulatory Lead (RL).
Support of CTIS submissions, amendments, notifications and regulatory interactions with regulatory authorities.
Management of post-authorisation activities, including variations, renewals, transfers and other lifecycle maintenance procedures.
Review and update of product information documents (SmPC, PIL, labelling texts) and artwork materials in compliance with local and EU requirements.
Coordination with internal project teams, clients and regulatory authorities to ensure timely and compliant submissions.
Tracking regulatory commitments, maintaining documentation and supporting regulatory strategy implementation.
Expected profile:
University degree in a life science discipiline
Previous regulatory affairs experience in CTA and MAA activities within the EU.
Good understanding of Czech/EU clinical trial and medicinal product legislation.
Experience with lifecycle management activities (variations, transfers, renewals) and product information maintenance.
Strong organizational skills, attention to detail and ability to manage multiple projects simultaneously.
Effective communication skills and ability to work independently in an international environment.
Fluent in English, written and spoken
