Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Regulatory Affairs Associate (CTA & MAA)
Job ID R0000045984 Prague, Hlavní město Praha, CzechiaWe 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
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