Country Approval Specialist at Thermo Fisher Scientific

Sydney, New South Wales, Australia

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous Start Up experience with submissions and contract negotiations (comparable to 1+ years) or equivalent
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
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment
Maintains knowledge of and understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Responsibilities

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, under guidance, local regulatory strategy advice (MoH &/or EC) to internal clients
Provide project specific local start-up services and coordination of these projects
Have contact with investigators for submission related activities
Key-contact at country level for either Ethical and Regulatory submission-related activities
Coordinate, under guidance, 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 target cycle times for site activation
May work with CRA(s) to prepare the regulatory compliance review packages, as applicable
Develop country specific Patient Information Sheet/Informed Consent form documents
Assist with grant budgets(s) and payment schedules negotiations with sites
Support the coordination of feasibility activities, as required, in accordance with agreed timelines
Enter and maintain trial status information relating to start-up activities onto internal tracking databases in an accurate and timely manner
Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs

Skills

Key technologies and capabilities for this role

regulatory submissionsMoH approvalsEC submissionsgene therapy approvalsviral safety dossiersimport licenseattention to detailclinical trialsstart-up operations

Questions & Answers

Common questions about this position

Is this a remote position or does it require office work?

This is an office-based role with standard Monday-Friday hours and office environmental conditions.

What are the main responsibilities of the Country Approval Specialist?

The role involves preparing, reviewing, and coordinating local regulatory submissions, providing local regulatory strategy advice, coordinating with investigators and internal teams, and supporting site activation activities.

What skills or qualities are ideal for this role?

Strong attention to detail, ownership of document accuracy, and accountability for yourself and others are essential.

What is the employment type for this position?

This is a full-time position.

What is the salary or compensation for this role?

This information is not specified in the job description.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

Land your dream remote job 3x faster with AI

Try Jobo Free