Associate Director, Regulatory Intelligence

The Regulatory Intelligence Lead monitors and analyzes global regulatory, scientific, and policy developments and translates external signals into actionable insights that support our company's portfolio, pipeline, and strategic priorities. The role conducts targeted research, precedent analyses, and competitor assessments; supports the Science & Regulatory Policy (SRP) team’s policy and advocacy activities; and leverages modern intelligence tools, including AI-enabled capabilities, to enhance horizon scanning, knowledge management, and decision-making across Regulatory Affairs. 

Key Responsibilities 

Horizon Scanning and External Monitoring 

• Monitor global regulatory, scientific, and policy developments across key health authorities and organizations (e.g., FDA, EMA, MHRA, PMDA, Health Canada, ICH, WHO) for changes relevant to our company's portfolio, pipeline, and strategic priorities. 

• Leverage public, subscription-based, and AI-enabled intelligence sources to identify emerging regulations, guidances, advisory committee outcomes, labeling developments, enforcement trends, and policy shifts. 

• Track competitor regulatory activities and maintain awareness of upcoming agency meetings, workshops, conferences, and public comment opportunities with strategic relevance to the business. 

• Maintain awareness of agendas and activities of key professional and patient organizations and scientific and regulatory policy groups for impact and opportunities pertinent to the business.  

• Maintain a forward-looking watchlist of high-impact regulatory and policy topics, including upcoming agency meetings, workshops, conferences, and public commenting opportunities pertinent to the business.  

Research & Intelligence Generation 

• Conduct targeted regulatory research including precedent analyses for regulatory pathways, approval decisions, labeling outcomes, post-marketing requirements, and advisory committee dynamics, to support business-critical questions and regulatory strategy. 

• Leverage a combination of public domain sources (e.g., FDA/EMA websites, Federal Register, EPARs, approval packages, inspection findings) and subscription-based tools, including AI-enabled search, monitoring, and knowledge management capabilities, to generate robust, evidence-based insights. 

• Perform structured benchmarking and precedent research to inform development strategy, regulatory positioning, and health authority engagement approaches. 

• Support ad hoc deep-dive analyses on emerging regulatory topics, scientific or policy inflection points, or specific agency actions, synthesizing findings into clear, decision-ready outputs.

• Ensure intelligence outputs are grounded in high-quality, traceable evidence, with appropriate documentation of sources and assumptions. 

Analysis and Insight Generation 

• Distill complex regulatory and policy information into concise, clear, and business-relevant insights for a range of internal audiences, including senior leadership. 

• Develop timely intelligence outputs such as alerts, briefing notes, landscape scans, trend analyses, and executive-ready summaries that clearly articulate the “so what, now what” associated risks, opportunities, and recommended next steps.  

• Inform stakeholders promptly of changes to the regulatory environment that could directly affect product programs, functional planning, or broader enterprise priorities. 

Policy Support and External Engagement Preparation 

• Work with Science & Regulatory Policy colleagues to identify and prioritize draft guidance, proposed regulations, consultation papers, and other public commenting opportunities relevant to our company’s business and strategic objectives.

• Coordinate internal review of comment opportunities, including gathering SME input, synthesizing feedback, and supporting development of company messaging for submission through appropriate channels (e.g., trade associations, direct engagement). 

• Provide evidence-based analyses, precedent assessments, competitive insights, and trend monitoring to inform SRP-led evaluations of regulatory risks, opportunities, policy scenarios, and health authority engagement strategies. 

• Support identification of opportunities to advance science-based regulatory policy, regulatory innovation, and efficient development approaches through targeted intelligence and external landscape assessments. 

Knowledge Management, Communications, and Capability Building 

• Manage and serve as subject matter expert for regulatory intelligence tools and databases; evaluate and implement enhancements to improve intelligence workflows.

• Leverage emerging technologies, including AI-enabled tools, automation, and advanced search capabilities, to enhance horizon scanning, signal detection, knowledge management, and intelligence dissemination processes.

• Support development of scalable intelligence repositories, dashboards, automated alerts, and knowledge-sharing approaches that improve organizational awareness and access to regulatory intelligence. 

• Develop internal communications, presentations, and training materials to increase regulatory awareness and support decision-making. 

• Help establish and refine regulatory intelligence processes, governance, and best practices.  

Qualifications 

Experience and Education 

Minimum of 5 years of experience in regulatory affairs and bachelor’s degree in a relevant discipline, or equivalent combination of: 

• Education and experience.

• Demonstrated experience monitoring, analyzing, and synthesizing regulatory and policy information to inform business decisions and support regulatory strategy. 

Skills 

• Strong analytical and synthesis skills; able to distill complex external changes into concise, decision‑ready insights. 

• Excellent writing skills, with the ability to communicate complex regulatory concepts in a clear and concise manner. 

• Familiarity with major regulatory frameworks (FD&C Act, FDA regulations and FDA web site, EMA regulations, ICH guidelines) and expedited pathways. 

• Familiarity with and ability to track and analyze relevant articles, op/ed’s and reports in mainstream and trade media, peer-reviewed scientific and medical journals, science and regulatory and public policy journals, policy papers, studies, and reports published by professional and patient advocacy groups and think tanks, newsletters, and other publications. 

• Proficiency with intelligence tools and knowledge management platforms (e.g., Cortellis, Federal Register/Regulations.gov, EMA/ICH portals, Copilot, SharePoint/Teams).