Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

LOCATION: Fully Remote, East Coast is highly preferred

Position Summary

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.

Key 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.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Qualifications and Skills

• 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

Thermo Fisher values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:

• 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.  (Recruiter will provide more details.)