Regulatory Intelligence Manager - FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

ROLE: Regulatory Intelligence Manager

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.

Qualifications and Skills

• 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 is a must

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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued