Sr Reg Affairs Spec at Thermo Fisher Scientific

Beijing, Beijing, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, 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 5+ years)
Strong English language (written and oral) communication skills as well as local language where applicable
Solid attention to detail and quality as well as strong editorial/proofreading skills
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Solid computer skills including the use of Microsoft Word, Excel, PowerPoint; capable of learning new technologies
Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
Solid negotiation skills
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to produce compliant deliverables
Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc
Solid understanding of medical terminology

Responsibilities

Serves as a senior contact in providing innovative solutions including regulatory expertise, interacting with clients to provide strategic regulatory 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
Prepares and reviews regulatory submissions
Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in implementing strategies
Leads the development and implementation of project-specific processes for sponsors
Collaborates extensively with other departments, regulatory consultants, and regulatory authorities
Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications
Provides training and guidance to junior team members as appropriate
Participates in project launch meetings, review meetings and project team meetings
Supports business development activities, including project budgeting/forecasting

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory SubmissionsICH GuidelinesRegulatory StrategyClinical ResearchProduct DevelopmentPreclinicalRegistration

Questions & Answers

Common questions about this position

What education and experience are required for this Senior Regulatory Affairs Specialist role?

A Bachelor's degree or equivalent and relevant formal academic/vocational qualification is required, along with previous experience comparable to 5+ years that provides the necessary knowledge, skills, and abilities.

What key skills are needed for this position?

Strong English language (written and oral) communication skills, solid attention to detail and quality, and strong editorial skills are essential, along with local language skills where applicable.

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

The position is based in office environmental conditions with a standard Monday-Friday work schedule.

What does the company culture emphasize at Thermo Fisher Scientific?

The culture focuses on meaningful work that positively impacts global health, providing resources for career goals, and enabling science to advance through research, development, and delivery of life-changing therapies.

What makes a strong candidate for this Sr Reg Affairs Spec role?

Candidates with 5+ years of relevant experience, strong communication and editorial skills, attention to detail, and the ability to provide regulatory strategy and lead project processes will stand out.

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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