FSP Country Approval Specialist (all level) at THERMO FISHER BIOPHARMA SERVICES PTE LTD

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

06 Oct, 26

Salary

0.0

Posted On

08 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submissions, Site Contract Negotiation, Budget Negotiation, Clinical Trial Start-up, Regulatory Strategy, Stakeholder Management, Clinical Trial Agreements, HSA Regulations, EC Regulations, Project Coordination, Risk Management, Documentation Quality, Microsoft Office, CTMS, Interpersonal Communication, Decision Making

Industry

Biotechnology Research

Description

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. • Demonstrated experience independently managing site contract and budget negotiations is required. • Experience working with multiple stakeholders across Clinical Operations, Legal, Finance, and Regulatory functions. 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: • Strong experience in site contract and budget negotiation with hospitals and investigative sites. • Solid understanding of clinical trial agreements , site budget development, and negotiation strategies. • 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 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 • Proficiency in Microsoft Office and clinical trial management systems. Working Conditions and Environment: • This is a fully remote position based in Singapore. • Occasional travel may be required for investigator meetings, sponsor meetings, or business needs. • Work is primarily performed in a home office environment with frequent interaction with global • project teams across multiple time zones. • Standard office equipment will be used in accordance with company policies. 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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Responsibilities

Manage the preparation and coordination of local regulatory submissions and provide strategy advice to internal clients. Lead site contract and budget negotiations while ensuring alignment with global submission strategies and study timelines.