Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Poland.

📋 Description

• Prepare and submit Part I and/or Part II applications in accordance with EU CTR and other regulatory requirements.

• Oversee regulatory activities assigned to support the initiation of clinical trials.

• Develop regulatory documents, Clinical Trial Application (CTA) packages, and submissions for designated countries.

• Organize regulatory timelines and deadlines for CTIS submissions across Europe, Asia-Pacific, and North America.

• Review regulatory documents and submissions prepared by subcontractors prior to CTIS submission.

• Act as the primary contact for sponsors, subcontractors, and project management teams in relation to regulatory submissions.

• Prepare or evaluate country-specific Patient Information Sheets and Informed Consent Forms.

• Create or assess study-specific regulatory form templates.

• Manage translation requests with external vendors.

• Offer regulatory support and guidance on local requirements, EU submission strategies, and technical issues.

• Keep abreast of EU CTR and EU/EEA local regulations.

• Maintain the regulatory intelligence database.

• Participate in kick-off meetings, audits, and other project-related discussions.

⛳️ Requirements

• Bachelor's degree (or equivalent) in a scientific field.

• A minimum of 2-3 years of clinical research experience (in CRO or Pharma) focusing on Romanian regulatory affairs is essential.

• Experience in initial CTA submissions is crucial.

• A background in a sponsor-facing role is an advantage.

• Prior experience with CTIS is beneficial.

• Practical experience in preparing, reviewing, and submitting regulatory documentation.

• Strong understanding of relevant EU regional and national regulatory guidelines.

• In-depth knowledge of GCP and ICH standards.

• Proficiency in English with outstanding oral and written communication skills is required.

• Knowledge of additional languages is a plus.

• Exceptional organizational and communication abilities, with a keen attention to detail.

• Capability to manage personal workload, prioritize various tasks, and maintain performance under pressure.

• Adaptable and comfortable in a fast-paced, multitasking environment.

• Ability to adhere to set timelines, expectations, priorities, and goals.

• Legally entitled to work in Poland.

🏝️ Benefits

• Permanent full-time employment.

• Flexible working hours.

• Paid vacation.

• Remote work opportunity.

• Continuous learning and professional development.

• Attractive opportunities for career advancement.

• Recruitment and selection accommodations for applicants with disabilities, available upon request.