A global clinical research organisation is seeking a Regulatory Affairs Specialist to join their growing team. This is a fantastic opportunity for an individual with strong EU CTR experience who is passionate about clinical trial submissions in a remote work environment.
If you're based in Poland or Spain this could be your next big career move!
Responsibilities :
* Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high-quality standards.
* Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions, including oversight of EU (mainly), APAC, and North America submissions.
* Review of regulatory documents and submissions created by subcontractors (CROs, regulatory vendors) to ensure they meet high-quality standards before submission to CTIS.
* Serve as the point of contact for Sponsors and subcontractors / project management teams regarding all aspects of study regulatory submissions.
* Preparation or review of country-specific Patient Information Sheets / Informed Consent Form documents.
* Preparation or review of study-specific regulatory form templates.
* Manage translation requests with vendors.
* Provide regulatory support and advice to project teams and internal / external customers on local regulatory requirements, EU submission strategies, and technical expertise.
* Maintain a high level of knowledge of EU CTR and local requirements in the EU / EEA countries relevant to the business.
* Maintain the regulatory intelligence database.
* Participate in Kick-off meetings, audits, and other project-related meetings as required.
Requirements :
* Bachelor's degree (or equivalent) in a scientific discipline
* 2+ years of experience in regulatory affairs and clinical research experience
* Strong EU CTR experience and hands-on experience with clinical trial submissions (CTIS, CTA)
* Sponsor-facing experience is a plus
* Knowledge of EU CTR guidelines
* Fluency in English, additional languages a plus
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