FSP Country Approval Specialist (all level)

Thermo Fisher ScientificRemote, SingaporeremoteSalary not postedView the original posting at Thermo Fisher Scientific ↗

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Specialist - Make an Impact at the Forefront of Innovation The 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. • 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: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Minimum 3-5 years of experience in clinical trial start-up, country approval, site activation, or regulatory affairs within the pharmaceutical, biotechnology, or CRO industry. • Demo

The people who work here are one introduction away.

We show you who they are and write your first message — the insider list for this posting is filling in now. You have one introduction. The rest follows.

People at Thermo Fisher Scientific you can reach out to

45 of 73 public LinkedIn profiles found in searches for Thermo Fisher Scientific list Thermo Fisher Scientific in their headline — those are the ones you can be confident work there. Pick who to reach out to — we'll draft your message; you make the contact. The rest, when shown, are marked Unverified.

Profiles are public pages as indexed by the search engine — we never log in to LinkedIn or copy private data, and anyone can ask to be removed. Ask to be removed →

Start the conversation More Site contracts jobs

Remote Site contracts jobs →Entry level Site contracts jobs →Senior Site contracts jobs →All Thermo Fisher Scientific jobs →