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; supportstheScience &Regulatory Policy(SRP)team’spolicy 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 company's portfolio, pipeline, and strategic priorities.

• Leverage public, subscription-based, and AI-enabled intelligence sources toidentifyemerging regulations,guidances, 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 dynamics,to 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 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, 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 company’sbusiness 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 bachelor’s 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 concise,decision-readyinsights.

• Excellent writingskills,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 publicpolicy journals,policy papers, studies, and reports published by professional and patient advocacy groupsandthinktanks,newsletters, and other publications.

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

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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