Sr Country Approval Specialist at Thermo Fisher Scientific

Seoul, South Korea, South Korea

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Life Sciences, BiotechnologyIndustries

Requirements

Over 1+ years of MFDS IND experience
Experience with MFDS initial submissions, amendment submissions, and notifications
Bachelor's degree or above
Academic background in Life Science, Nursing, Biology, Pharmaceutical Science preferred
Maintains knowledge of and understands TFS(PPD) SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Responsibilities

Participates in the management and preparation, review, and coordination of Country Submissions in line with global submission strategy
Under guidance, prepares, reviews, and coordinates local regulatory submissions (MoH and additional special national local applications as applicable) in alignment with the global submission strategy
Provides, under guidance, local regulatory strategy advice (MoH) to internal clients
Works on various regulatory affairs including maintenance and application of clinical trials, regulatory problem solving, giving consultation of local regulatory requirements
Coordinates with internal functional departments to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines
In collaboration with other departments, and in accordance with the Regulatory Authority Communication Policy, serves as a contact with MoH for application activities
Compiles and submits initial applications, substantial amendments, periodic reports, and notification reports
May have contact with investigators for submission related activities
Achieves PPD’s target cycle times
Develops country specific labels and patient cards
Ensures and maintains trial status information relating to start-up activities onto PPD tracking databases in an accurate and timely manner
Ensures the local country study files and filing processes are prepared, set up and maintained as per TFS(PPD) SOP/WPDs or applicable client SOPs

Skills

MFDS IND

MFDS Submissions

MoH Submissions

Regulatory Affairs

Clinical Trials

Country Approvals

SOP Compliance

Regulatory Strategy

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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