Country Approval Specialist - FSP - EMEA

Position Overview

Join our dynamic global team as a Country Approval Specialist – FSP – EMEA and play a pivotal role in advancing innovative pharmaceutical and biotech solutions across 100+ countries. With a proven track record of supporting the top 50 pharmaceutical companies and over 750 biotechs in 2,700 clinical trials over the past five years, you will contribute to the strategic management, preparation, review, and coordination of country-specific regulatory submissions. This role is instrumental in ensuring submissions align with global strategies while adhering to local regulatory requirements, making it an ideal opportunity for professionals seeking to leverage their expertise in a fast-paced, impactful environment.

Key Responsibilities

As a Country Approval Specialist, your core responsibilities will include:

• Submission Management: Prepare, review, and coordinate local regulatory submissions, including applications to Ministries of Health (MoH), Ethics Committees (EC), and other national authorities. This may involve specialized submissions such as gene therapy approvals, viral safety dossiers, or import licenses, all in alignment with the global submission strategy.
• Regulatory Strategy Support: Provide local regulatory strategy advice to internal stakeholders, including MoH and EC, ensuring submissions are optimized for success and compliance.
• Project Coordination: Deliver project-specific regulatory services and coordinate activities to ensure seamless alignment with internal teams and external partners. This includes liaising with investigators for submission-related activities and serving as the primary contact for ethical or regulatory submission matters at the country level.
• Cross-Functional Collaboration: Work closely with internal departments to align site start-up activities with submission timelines, ensuring mutual agreement on critical milestones. Contribute to the preparation of regulatory compliance review packages and develop country-specific Patient Information Sheets/Informed Consent Form documents as needed.
• Budget and Feasibility Support: Assist with grant budget negotiations and payment schedules with sites, while supporting feasibility activities to meet agreed-upon timelines.
• Data Management and Compliance: Maintain accurate and timely trial status information in PPD tracking databases, ensuring local country study files and filing processes adhere to PPD Work Practice Documents (WPDs) or client-specific Standard Operating Procedures (SOPs). Stay updated on PPD SOPs, client directives, and current regulatory guidelines relevant to your role.

Qualifications and Requirements

To excel in this role, you should meet the following criteria:

• Education: A Bachelor’s degree or equivalent in a relevant field, along with formal academic or vocational qualifications. Alternatively, an equivalency combining education, training, and directly related experience may be considered.
• Experience: A minimum of 2+ years of relevant experience, providing the knowledge, skills, and abilities to perform the job effectively.
• Knowledge and Skills:
  • Strong oral and written communication skills, with excellent interpersonal abilities.
  • Meticulous attention to detail and a commitment to maintaining high-quality documentation.
  • Proficient negotiation skills and the ability to work independently or as part of a team under direction.
  • Solid computer skills and the capacity to learn new software tools efficiently.
  • Fluency in English, with strong grammar and language proficiency.
  • Basic understanding of medical/therapeutic area terminology and regional/national regulatory guidelines, including EC regulations.
  • Organizational and planning skills to manage multiple tasks and deadlines effectively.

Work Environment and Conditions

This role operates in a professional office environment, with potential exposure to biological fluids and infectious organisms in clinical or laboratory settings. Standard office equipment, including computers and protective gear such as eyewear, garments, and gloves, will be utilized. The position requires adherence to safety protocols and compliance with all applicable regulatory guidelines.