Thermo Fisher Scientific · 15 hours ago
Principal Reg Affairs Specialist
Juneau, AK
Full-time
Onsite
Lead/Staff
8+ years expThermo Fisher Scientific is a leading company in the pharmaceutical and biotech industry, supporting numerous clinical trials globally. The Principal Regulatory Affairs Specialist will provide strategic regulatory intelligence and guidance throughout product development, ensuring compliance with local and international regulations while leading projects and mentoring junior team members.
Research
Responsibilities
Provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements
Acts as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available
Participates in project management activities to support the provision of regulatory services, and acts as liaison with internal and external clients in the provision of marketing these services
Provides matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables
May provide input on performance reviews to management
Ensures adherence to project budgets, time schedules, and scope of work
Ensures compliance with relevant organizational and regulatory SOPs and WPDs
Contributes to business development activities, including project budgeting/forecasting
Qualification
Required
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 8+ years)
Excellent English language (written and oral) communication skills as well as local language where applicable
Great attention to detail and quality as well as excellent editorial/proofreading skill
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Strong computer skills including the use of Microsoft Word, Excel, Power Point; 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
Strong negotiation skills
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
Strong understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; good understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc
Strong understanding of medical terminology, statistical concepts, and guidelines
Excellent analytical, investigative and problem-solving skills
Solid understanding of budgeting and forecasting
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
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
Company data provided by crunchbase