Regulatory Affairs Specialist

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