Job Description
Job Description Join Us as a Country Approval Specialist - Make an Impact at the Forefront of InnovationThe 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 (HSA, 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 (HSA &/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.Lead site contract and budget negotiations with investigative sites and institutions, ensuring timely execution while maintaining compliance with sponsor requirements, local regulations, and company standards.Independently manage complex contract and budget negotiations, balancing study timelines, financial objectives, and site relationship management.Partner closely with Legal, Clinical Operations, Project Management, and Finance to resolve contract and budget issues that may impact study timelines.Identify, escalate, and proactively resolve contract, budget, and regulatory risks that could delay site activation.Ensure country submission activities remain on the critical path for study start-up and achieve target cycle times.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.
Responsibilities + Skills
Education
Solid understanding of clinical trial agreements , site budget development, and negotiation strategies.Effective oral and written communication skillsExcellent interpersonal skillsStrong attention to detail and quality of documentationGood negotiation skillsGood computer skills and the ability to learn appropriate softwareGood judgment and decision-making skillsBasic medical/therapeutic area and medical terminology knowledgeAbility to work in a team environment or independently, with minimal supervision, as requiredAbility to mentor fellow SIA team members in a positive and effective mannerExcellent team player with teambuilding skills
Experience
