Country Approval Specialist / Sr Country Approval Specialist

Work Schedule

Environmental Conditions

Job Description

Join Us as a Site Activation & Country Approval Specialist

Make an Impact at the Forefront of Innovation

At Thermo Fisher Scientific, our Clinical Research team supports leading pharmaceutical, biotechnology, and emerging biopharma companies in advancing innovative therapies worldwide. Having contributed to thousands of clinical trials across more than 100 countries, we are committed to accelerating research that improves patient lives.

As a Site Activation & Country Approval Specialist, you will play a key role in the successful start-up of clinical trials by supporting regulatory submissions, site activation activities, and country-specific requirements. Working closely with investigative sites, regulatory authorities, sponsors, and internal teams, you will help drive efficient study start-up while ensuring compliance with local regulations, company procedures, and global project strategies.

Position Summary

The Site Activation & Country Approval Specialist is responsible for supporting and coordinating site activation and regulatory submission activities to ensure clinical studies are initiated efficiently and in compliance with applicable regulations. This role partners with cross-functional teams to manage submission strategies, site documentation, regulatory approvals, site agreements, and start-up timelines while maintaining high standards of quality, accuracy, and operational excellence.

Key Responsibilities:

• Coordinate and support site activation activities to achieve study start-up timelines and project milestones.
• Prepare, review, and manage regulatory submissions to local regulatory authorities, ethics committees, and other applicable agencies.
• Support the development and execution of country-specific regulatory and site activation strategies.
• Prepare and maintain essential site and regulatory documentation in accordance with local regulations and company procedures.
• Assist with site agreement negotiations, budgets, and essential document collection.
• Collaborate with investigators, study sites, sponsors, and internal stakeholders to facilitate timely site activation and regulatory approvals.
• Serve as a key contact for submission and site activation activities at the country level.
• Ensure compliance with SOPs, client requirements, ICH-GCP guidelines, and applicable regulatory standards.
• Coordinate with internal departments to align submission, contracting, and activation activities with study timelines.
• Monitor and maintain accurate trial status information and study records within company systems.
• Support regulatory compliance reviews and inspection readiness activities.
• Identify, escalate, and support resolution of regulatory or start-up issues that may impact project timelines.
• Contribute to process improvement initiatives and share best practices across teams.
• Provide guidance and mentoring to team members, when applicable.

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Healthcare, Regulatory Affairs, or a related field, or an equivalent combination of education and experience.
• Strong understanding of clinical research processes and site start-up activities.

Experience:

• Relevant experience in clinical trial start-up, site activation, regulatory submissions, clinical operations, or related areas within a pharmaceutical, biotechnology, CRO, or healthcare environment.
• Candidates may be considered for Site Activation Specialist or Senior Country Approval Specialist opportunities based on their experience, qualifications, regulatory expertise, and demonstrated knowledge of country-specific approval processes.

Preferred Skills & Competencies:

• Knowledge of clinical trial start-up processes, regulatory submissions, and site activation activities.
• Understanding of ICH-GCP guidelines and applicable regional and local regulatory requirements.
• Experience working with ethics committees, regulatory authorities, and investigative sites.
• Strong organizational and project coordination skills.
• Excellent communication and stakeholder management abilities.
• Strong attention to detail and quality-focused mindset.
• Effective negotiation and problem-solving skills.
• Ability to work independently and collaboratively in a global environment.
• Experience managing multiple priorities and competing deadlines.
• Ability to mentor and support colleagues, where applicable.
• Proficiency with Microsoft Office and clinical trial management systems.
• English proficiency required.

Working Conditions & Environment

• Work is performed in an office and/or home-based environment with exposure to standard office equipment and technology.
• May collaborate with global teams across multiple time zones.
• Requires the ability to manage multiple priorities and deadlines in a fast-paced clinical research environment.