Senior/Principal - Country Approval Specialist

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior/Principal Country Approval Specialist - Make an Impact at the Forefront of Innovation The Senior/Principal Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy. What You'll Do: • Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. • Provide local regulatory strategy advice (MoH &/or EC) to internal clients. • Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments. • Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner. • Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner. • Act as a key-contact at country level for all submission-related activities. • Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings. • Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation. • Achieve company’s target cycle times for site activations. • Prepare the regulatory compliance review packages, as applicable. • Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy. • Develop country specific Patient Information Sheet/Informed Consent form documents. • May assist with grant budgets(s) and payment schedules negotiations with sites. • Assist in identifying and recognizing 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. • Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times. • Oversee country study files and ensure that that they meet PPD WPD’s or client SOP’s. • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. • Direct/mento other SIA individuals assigned to support projects of responsibility, as appropriate • Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate. Education & Experience Requirements: For Senior Country Approval Specialist: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (2+ years direct startup experience in CRO/Sponsor setting or comparable to 5+ years relevant experience). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. For Principal Country Approval Specialist: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (5+ years direct startup experience in CRO/Sponsor setting or comparable to 8+ years relevant experience). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities: • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and the ability to learn appropriate software • Good English language and grammar skills • Good judgment and decision-making skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, with minimal supervision, as required • Ability to mentor fellow SIA team members in a positive and effective manner • Excellent team player with teambuilding skills • Basic organizational and planning skills • Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.