Principal Country Approval Specialist

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

📋 Description

• Prepare, review, and coordinate local regulatory submissions in accordance with the global submission strategy.

• Offer local regulatory strategy guidance to internal clients.

• Provide project-specific submission strategy, technical expertise, and coordination oversight.

• Act as the primary liaison for investigators and local regulatory authorities.

• Ensure compliance with submission guidelines, processes, and communications.

• Serve as the key country-level contact for submission-related tasks.

• Participate in submission, review, and project team meetings.

• Coordinate site start-up activities with internal functional departments.

• Meet company target timelines for site activations.

• Prepare regulatory compliance review packages with start-up Clinical Research Associates (CRAs).

• Develop country-specific Patient Information Sheets and Informed Consent forms.

• Assist in negotiating grant budgets and payment schedules.

• Identify local out-of-scope contract activities and advise relevant functions accordingly.

• Support feasibility activities.

• Maintain accurate and up-to-date trial status information in databases.

• Oversee country study files to ensure compliance with PPD Work Product Documents (WPD) or client Standard Operating Procedures (SOPs).

• Stay informed about company and client SOPs as well as current regulatory guidelines.

• Direct or mentor other members of the SIA team.

• Prepare and maintain country master document templates and regulatory intelligence systems.

⛳️ Requirements

• Bachelor's degree or equivalent, along with relevant formal academic or vocational qualifications.

• A minimum of 8 years of experience, or comparable knowledge, skills, and abilities.

• A combination of relevant education, training, and/or directly related experience may be considered as an equivalency.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• Exceptional attention to detail and documentation quality.

• Solid negotiation capabilities.

• Proficient computer skills with the ability to learn new software quickly.

• Proficient in English and Polish, with strong grammar skills.

• Good judgment and decision-making abilities.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Ability to work independently or as part of a team with minimal supervision.

• Capability to mentor fellow SIA team members.

• Strong organizational and planning skills.

• In-depth knowledge of relevant regional/national regulatory guidelines and European Commission regulations.

🏝️ Benefits

• Award-winning learning and development program.

• Opportunities for professional and personal career growth.

• A diverse and inclusive team environment.

• Collaboration with a global team.

• Recognition of the strength in teamwork.