[Remote] Regulatory Affairs Specialist at Thermo Fisher Scientific

Philippines

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Good English language (written and oral) communication skills as well as local language where applicable
Good attention to detail and quality as well as editorial/proofreading skills
Good interpersonal skills to work effectively in a team environment
Good computer skills including the use of Microsoft Word, Excel, PowerPoint; capable of learning new technologies
Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
Good negotiation skills
Capable of working independently with direction and exercising independent judgment
Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables
Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
Basic understanding of medical terminology, statistical concepts, and guidelines
Good analytical, investigative and problem-solving skills
Capable of interpreting data
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary for typical working hours
Ability to use and learn standard office equipment and technology with proficiency
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
May require travel

Responsibilities

Supports the preparation of documentation and submissions under guidance
Coordinates and manages client deliverables supporting regulatory compliance
Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects
Assists with project budgeting/forecasting
Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines
Assists in business development and pricing of projects for the department
Evaluates client needs in relationship to overall project timelines, quality and delivery
Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed
Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization
Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements
Acts as liaison with internal and external clients in the provision and marketing of these services

Skills

Regulatory Affairs

ICH Guidelines

Regulatory Submissions

SOPs

Project Management

Client Liaison

Business Development

Regulatory Compliance

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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