[Remote] Regulatory Intelligence Manager - FSP at Thermo Fisher Scientific

Pennsylvania, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor’s degree in life sciences or related field; advanced degree preferred
5+ years of specialized experience in regulatory intelligence within the biopharmaceutical industry
Strong understanding of global regulatory frameworks and drug development lifecycle
Excellent analytical, writing, and presentation skills. Perfect command of English
Proven ability to translate complex regulatory information into actionable insights
Strong project management and prioritization skills; ability to effectively manage multiple tasks and priorities
Experience with regulatory intelligence tools and databases (e.g., Clarivate, Citeline, etc.) as well as proficiency with generative AI concepts and use
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience

Responsibilities

Monitor & Analyze: Track global regulatory changes, guidance documents, and policy trends across key markets (FDA, EMA, PMDA, etc.) or stakeholders (EU Commission, ICH, ISO, etc.)
Impact Assessment: Liaise with relevant internal stakeholders and evaluate the implications of regulatory updates on the client's development programs and operational practices
Stakeholder Alignment: Interact with Regulatory Affairs, Clinical, Quality, Pharmacovigilance and Legal teams to ensure alignment and awareness with key areas of interest and hot topics
Communication: Contribute to the creation of and distribute internal newsletters, alerts, and briefing documents tailored to various audiences. Publish relevant selected content to internal Engage forum
Precedent Searches: Contribute to preparatory research and drafting of responses to precedent searches requests from various stakeholders
Knowledge Management: Maintain a centralized repository of regulatory intelligence resources and ensure accessibility across teams
External Engagement: Participate in industry forums, working groups, and regulatory intelligence networks to stay ahead of emerging trends

Skills

Key technologies and capabilities for this role

Regulatory IntelligenceFDAEMAPMDAICHISORegulatory AffairsPharmacovigilanceStakeholder ManagementImpact AssessmentPolicy Analysis

Questions & Answers

Common questions about this position

Is this position remote?

The position is fully remote, with the East Coast highly preferred.

What qualifications are required for the Regulatory Intelligence Manager role?

Candidates need a Bachelor’s degree in life sciences or related field (advanced degree preferred), 5+ years of specialized experience in regulatory intelligence within the biopharmaceutical industry, strong understanding of global regulatory frameworks and drug development lifecycle, excellent analytical, writing, and presentation skills, and perfect command of English.

What is the salary for this position?

This information is not specified in the job description.

What does the company culture at Thermo Fisher Scientific emphasize?

The company emphasizes meaningful work that positively impacts global health, providing resources for individual career goals, and advancing science through research, development, and delivery of life-changing therapies.

What makes a strong candidate for this role?

A strong candidate will have 5+ years of specialized regulatory intelligence experience in biopharma, an advanced degree in life sciences, proven skills in analyzing global regulations and communicating insights to cross-functional teams like Regulatory Affairs, Clinical, and Quality.

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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