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 companys portfolio pipeline and strategic priorities. The role conducts targeted research precedent analyses and competitor assessments; supportstheScience &Regulatory Policy(SRP)teamspolicy and advocacy activities; andleveragesmodern 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 companys portfolio pipeline and strategic priorities.

• Leverage public subscription-based and AI-enabled intelligence sources toidentifyemerging regulationsguidances advisory committee outcomes labeling developments enforcement trends and policy shifts.

• Track competitor regulatory activities andmaintainawareness 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 andregulatory policy groups forimpact 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 dynamicsto support business-critical questionsand regulatory strategy.

• Leverage a combination of public domain sources (e.g. FDA/EMA websites Federal Register EPARs approval packages inspection findings) and subscription-based toolsincluding AI-enabled search monitoring and knowledge management capabilitiesto 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 withappropriate documentationof sources and assumptions.

Analysisand Insight Generation

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

• Developtimelyintelligence 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 withScience &Regulatory Policy colleagues toidentifyand prioritize draft guidance proposed regulations consultation papers and other public commenting opportunities relevant to our companysbusiness and strategicobjectives.

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

• Provide evidence-based analyses precedent assessments competitive insights and trendmonitoringto 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.

• Supportdevelopmentof 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.

• Helpestablishand refine regulatory intelligence processes governance and best practices.

Qualifications

Experience andEducation

Minimumof5 yearsof experience in regulatory affairs and bachelors degree in a relevant discipline or equivalent combination of:

• Education and experience.

• Demonstratedexperience 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 concisedecisionreadyinsights.

• Excellent writingskillswith 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/eds and reports in mainstream and trade media peer-reviewed scientific and medical journals science and regulatory and publicpolicy journalspolicy papers studies and reports published by professional and patient advocacy groupsandthinktanksnewsletters and other publications.

• Proficiencywith intelligence tools and knowledge management platforms (e.g.Cortellis Federal Register/ EMA/ICH portals Copilot SharePoint/Teams).