FSP Country Approval Specialist at Thermo Fisher Scientific

Melbourne, Victoria, Australia

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, Life SciencesIndustries

Requirements

Home-based position, preferably based in Melbourne, Sydney, Brisbane, Adelaide or Perth
Ability to manage preparation, review, and coordination of Country Submissions in line with global submission strategy
Knowledge of local regulatory submissions (MoH, EC, special national applications e.g., gene therapy approvals, viral safety dossiers, import license)
Expertise in providing local regulatory strategy advice (MoH &/or EC)
Technical expertise and coordination oversight for projects with internal departments
Capability to serve as primary contact for investigators and local regulatory authorities
Understanding of guidelines and processes for communications with internal teams, investigators, and regulatory authorities
Ability to act as key-contact at country level for submission-related activities
Participation in Submission Team Meetings, Review Meetings, and Project Team meetings
Coordination with internal functional departments for site start-up activities and timelines
Achievement of target cycle times for site activations
Preparation of regulatory compliance review packages
Liaison within SIA locally for alignment with global project submission strategy
Development of country-specific Patient Information Sheet/Informed Consent form documents
Assistance with grant budgets and payment schedules negotiations with sites
Identification and recognition of local out-of-scope activities in contracts
Support for coordination of feasibility activities

Responsibilities

Prepares, reviews, and coordinates 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
Provides local regulatory strategy advice (MoH &/or EC) to internal clients
Develops and implements local submission strategy
Serves 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
Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators and with the country regulatory authorities to ensure submissions are managed in a timely manner
Acts as a key-contact at country level for all submission-related activities
Participates as required in Submission Team Meetings, Review Meetings, and Project Team meetings
Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
Achieves PPD’s target cycle times for site activations
Prepares the regulatory compliance review packages, as applicable
Liaises within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy
Develops country specific Patient Information Sheet/Informed Consent form documents
May assist with grant budgets and payment schedules negotiations with sites
Assists in identifying and recognising local out of scope activities in a contract in a timely manner and advise relevant functions
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines
Ensures that trial status information relating to SIA activities

Skills

Country Submissions

Regulatory Submissions

MoH

Clinical Trials

Startup Activities

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.

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