Associate Director, Regulatory Intelligence

EyeBio

Rockville (MD)

Hybrid

USD 129,000 - 203,000

Full time

4 days ago

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Benefits offered by this job

Medical, Dental, Vision

401(k) Plan

Hybrid work arrangements

Job summary

EyeBio is seeking a Regulatory Intelligence Lead to monitor global regulatory and policy developments, translate signals into actionable insights, and support portfolio decisions. You will conduct horizon scanning, research regulatory pathways, and leverage AI-enabled tools to strengthen knowledge management and decision-making across Regulatory Affairs.

Based in the United States, you will generate concise intelligence outputs, collaborate with SRP colleagues on policy opportunities, and help

Qualifications

Minimum of 5 years of experience in regulatory affairs.
Bachelor’s degree in a relevant discipline or equivalent combination.
Demonstrated experience monitoring, analyzing, and synthesizing regulatory and policy information to inform business decisions.

Responsibilities

Monitor regulatory and policy developments across major health authorities and organizations.
Use public and AI-enabled sources to identify regulatory changes and policy shifts.
Benchmark and research regulatory precedents to inform development strategy.
Prepare ad hoc analyses and decision-ready outputs for regulatory strategy.
Ensure outputs are grounded in high-quality, traceable evidence.

Skills

Adaptability

Benchmarking

Building Capability

Change Management

Complex Analysis

Engagement Strategies

FDA Regulations

Knowledge Management

Knowledge Management Systems

Public Policies

Regulatory Affairs Management

Regulatory Compliance

Regulatory Labeling

Regulatory Operations

Regulatory Processes

Regulatory Research

Regulatory Submissions

Research Analysis

Strategic Thinking

Education

Bachelor’s degree in a relevant discipline

Tools

Cortellis

Federal Register/Regulations.gov

EMA/ICH portals

Copilot

SharePoint/Teams

Job description

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.

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 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.
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 and 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/eds 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).

Required Skills

Adaptability
Benchmarking
Building Capability
Change Management
Complex Analysis
Engagement Strategies
FDA Regulations
Knowledge Management
Knowledge Management Systems
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Labeling
Regulatory Operations
Regulatory Processes
Regulatory Research
Regulatory Submissions
Research Analysis
Strategic Thinking

Preferred Skills

Publishing Research
Researching
Scientific Research

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. If you need an accommodation during the application or hiring process.

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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EEOC GINA Supplement

$129,000.00 - $203,100.00

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

Job Details