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