Regulatory Intelligence Senior Manager

Thermo Fisher Scientific•Morrisville, NC

1d•Remote

About The Position

The Regulatory Intelligence Manager will play a pivotal role in monitoring, analyzing, and communicating global regulatory developments that impact the client's pipeline and operations. This individual will serve as a strategic partner to cross-functional teams, ensuring timely dissemination of insights and proactive regulatory strategy alignment.

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
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

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.

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