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Clinical Research Professional
7 days ago
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.
Our expertise includes full service capabilities, resourcing, and Functional Service (FSP) solutions. We provide tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas.
The Regulatory Affairs Manager is part of the Project Delivery organization and will work operationally on preparing, conducting, and completing Regulatory Affairs tasks in assigned Study Teams, according to company policies, SOPs, and regulatory requirements.
This is a freelance role requiring a commitment of 1–2 days per week, and the candidate is expected to work on-site in an office located in Copenhagen.
Key Responsibilities
- Provide regulatory services to support international multinational clinical trials in accordance with client requests.
- Prepare, review, and compile regulatory submissions.
- Liaise with regulatory authorities and provide expert advice on regulatory questions/issues.
- Maintain electronic files and regulatory trackers as required.
- Submit and support clinical trial applications to regulatory authorities within the EU.
- Develop regulatory documents for clinical trial submissions and scientific advice meetings.
- Act as a Project Lead for regulatory-only projects when required.
- Provide regulatory strategy and guidance to sponsors and internal teams to ensure compliance with regulations.
- Participate in meetings, share regulatory intelligence, and contribute to continuous improvement initiatives.
- Assist in the development and maintenance of department SOPs and tools.
- Stay updated on international regulatory requirements and procedures.
- Provide training and supervision to new regulatory personnel.
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