Country Approval Specialist at Thermo Fisher Scientific

Mumbai, Maharashtra, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Demonstrated background in clinical trials (clinical operations) study startup &/or regulatory affairs
Strong knowledge of clinical trial regulations and guidelines
Outstanding organizational skills and attention to detail
Ability to collaborate effectively with diverse teams
Excellent communication and interpersonal skills
Bachelor's degree in Life Sciences, Pharmacy, or a related field

Responsibilities

Determine and prepare country-specific submission dossiers for DCGI & EC meeting regulatory requirements for clinical trial submissions
Successfully implement submission strategies to acquire regulatory and ethics committee approvals
Forecast timelines for the critical activities
Liaise with regulatory authorities and investigators to facilitate approval processes
Collaborate with cross-functional teams to ensure timely and accurate documentation, optimise study startup timelines
Obtain and review essential documents, ensure systems updation and filing
Monitor and ensure compliance with local and international regulations
Work and drive the amendments and support the ongoing submissions, notifications for the ongoing studies
Provide guidance and support to project teams on local regulatory and GCP requirements, timelines and strategy

Skills

Clinical Trials

Study Startup

Regulatory Affairs

DCGI Submissions

Ethics Committee

GCP

Regulatory Compliance

Submission Strategies

Document Management

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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