Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

Senior Regulatory Intelligence Manager

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

46 days ago

Salary

Not specified

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

• 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.

Job Requirements

  • Bachelor’s degree in life sciences or related field; advanced degree preferred.
  • 10+ years of specialized experience in regulatory intelligence in US, EU and global (in the order of preference) 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 is a must.
  • Available for approximately 20% travel.
  • Business-level English proficiency required, additional languages beneficial.

Benefits

  • Health and wellbeing support
  • Flexible work arrangements

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