Associate Director, Regulatory Intelligence

Job Description

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.

• 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.
  
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• Leverage public, subscription-based, and AI-enabled intelligence sources to - identify - emerging regulations, - guidances , advisory committee outcomes, labeling developments, enforcement trends, and policy shifts.
  
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• Track competitor regulatory activities and - maintain - awareness of upcoming agency meetings, workshops, conferences, and public comment opportunities with strategic relevance to the business .
  
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• Maintain awareness of agenda s a nd activities of key professional and patient organizations and scientific and - regulatory policy groups for - impact and opportunities pertinent to the business.
  
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• 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.
  
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• 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.
  
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• 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.
  
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• Perform structured benchmarking and precedent research to inform development strategy, regulatory positioning, and health authority engagement approaches.
  
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• 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.
  
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• Distill complex regulatory and policy information into concise, clear, and business-relevant insights for a range of internal audiences, including senior leadership.
  
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• 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.
  
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• Inform stakeholders promptly of changes to the regulatory environment that could directly affect product programs, functional planning, or broader enterprise priorities.
  
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• 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).
  
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• 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 .
  
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• Support identification of opportunities to advance science-based regulatory policy, regulatory innovation, and efficient development approaches through targeted intelligence and external landscape assessments.
  
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• Manage…