Sr. Country Approval Specialist/Principal Country Approval Specialist

About the Role

Day-to-day, the Sr. Country Approval Specialist/Principal Country Approval Specialist will prepare, review, and coordinate local regulatory submissions, ensuring that all necessary documentation is in place. This includes developing and implementing local submission strategies, providing technical expertise, and coordinating with internal departments to align submission activities with site start-up activities. The role requires strong attention to detail, excellent communication skills, and the ability to work effectively in a team environment.

The ideal candidate will have a strong background in regulatory affairs, with experience in managing local regulatory submissions and developing submission strategies. They will be able to work independently, with minimal supervision, and will be able to build strong relationships with internal stakeholders and external partners.

What You Will Do

• Prepare, review, and coordinate local regulatory submissions in alignment with the global submission strategy
• Develop and implement local submission strategies, providing technical expertise and coordination oversight for projects
• Serve as primary contact for investigators and local regulatory authorities, ensuring timely submissions
• Ensure guidelines and processes are followed for effective internal team communications and external communications with investigators and regulatory authorities
• Act as a key contact at the country level for all submission-related activities
• Participate in Submission Team Meetings, Review Meetings, and Project Team meetings as required
• Coordinate with internal functional departments to align site start-up activities with submission activities
• Achieve company target cycle times for site activations
• Prepare regulatory compliance review packages as applicable
• Liaise with local teams to ensure local submission activity is planned and delivered in accordance with the global project submission strategy
• Develop country-specific Patient Information Sheet/Informed Consent form documents
• Assist with grant budgets and payment schedules negotiations with sites
• Identify and recognize local out-of-scope activities in a contract in a timely manner and advise relevant functions
• Support the coordination of feasibility activities, as required, in accordance with agreed timelines
• Maintain accurate and up-to-date trial status information relating to submission activities
• Oversee country study files, ensuring they meet PPD WPD's or client SOP's
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines

What We Are Looking For

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• Previous experience in regulatory affairs, with a focus on local regulatory submissions
• Strong attention to detail and quality of documentation
• Excellent interpersonal and communication skills
• Ability to work effectively in a team environment
• Strong negotiation skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to learn appropriate software and systems
• Good English language and grammar skills
• Good judgment and decision-making skills

Nice to Have

• Experience with Excel and other Microsoft Office applications
• Knowledge of local regulatory requirements and guidelines
• Experience in managing multiple projects simultaneously
• Certification in regulatory affairs or a related field

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a leading medical device company
• Collaborative and dynamic work environment
• Professional development and training opportunities
• Flexible working hours and remote work options
• Access to cutting-edge technology and equipment
• Comprehensive health insurance and wellness programs
• Generous paid time off and holiday entitlement
• Retirement savings plan and matching contributions

• Ensure your Excel skills are up-to-date, as this is a key requirement for the role. Practice using pivot tables, macros, and other advanced features to stand out.
• Highlight your experience in regulatory affairs, particularly in managing local regulatory submissions. Be prepared to give specific examples of your achievements in this area.
• Research Thermo Fisher Scientific's products and services to understand their commitment to innovation and customer satisfaction. This will demonstrate your interest in the company and the role.
• Prepare to discuss your experience working in a team environment and your ability to build strong relationships with internal stakeholders and external partners.
• Be prepared to ask questions about the company culture, opportunities for professional development, and the team you will be working with. This will show your interest in the role and the company.
• Consider creating a portfolio of your work, including examples of your submission strategies and regulatory compliance review packages. This will demonstrate your skills and experience to potential employers.
• When negotiating salary, be sure to research the market rate for the role and highlight your relevant skills and experience. This will help you make a strong case for your desired salary.