Regulatory Affairs Manager

Overview

Reporting to the VP, the Manager drives day-to-day execution of Massachusetts regulatory processes, including DoN and other DPH-related approvals, filings, and reporting obligations. The role coordinates cross-functional inputs, manages workplans/timelines and trackers, and maintains decision logs and submission-ready documentation. The Manager drafts, assembles, and quality-checks regulatory submissions and public-process materials, and coordinates post-approval conditions and required reporting. The Manager monitors Massachusetts developments (and assigned federal items) and prepares first-draft impact summaries and decision memos for VP review, escalating risks and key decisions as needed.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Primary Duties and Responsibilities:

• Execute day-to-day regulatory project delivery: Manages coordination of Massachusetts regulatory projects (primarily DoN and other licensure/approval processes) by developing workplans, timelines, stakeholder coordination plans, and deliverable tracking to support on-time submissions and responses.
• Maintain enterprise trackers and documentation: Owns the master DoN/state approvals tracker (milestones, dependencies, risks/issues, decisions, owners, due dates) and maintains decision logs, version control, and audit-ready supporting documentation; provides regular status updates to the VP and cross-functional stakeholders.
• Run internal submission workflows: Coordinates the internal DoN submission process by convening stakeholders, managing inputs and approvals, and ensuring filings are complete, consistent, and submission ready.
• Develop and quality-check application materials: Drafts, assembles, and quality-checks DoN and related regulatory materials (e.g., narratives, supporting documentation, data tables, attestations) in collaboration with clinical, operational, finance, community health, legal, and communications partners.
• Support public-process requirements and engagement: Prepares meeting materials, public-facing narratives, Q&A, and briefing documents in coordination with internal partners and under the direction of the Director.
• Manage post-approval obligations and reporting: Tracks conditions and reporting requirements for DoN and other approvals, confirms internal owners, maintains reporting calendars, and coordinates timely progress and final reports to agencies.
• Monitor developments and draft internal updates: Tracks Massachusetts regulatory developments (and assigned federal items) and prepares executive-ready summaries and first-draft impact notes for VP review; supports internal review/approval workflows as needed.

Knowledge, Skills and Abilities:

• Regulatory knowledge (applied): Working knowledge of U.S. healthcare regulation and the practical implications of regulatory requirements for clinical operations, research administration, and healthcare organizations.
• Massachusetts process familiarity (preferred): Demonstrated familiarity with Massachusetts healthcare regulatory processes strongly preferred, including DoN pathways, DPH interactions, documentation expectations, and post-approval reporting/conditions management.
• Project execution in a matrix: Ability to manage complex, deadline-driven projects with multiple stakeholders, dependencies, and approval steps; strong organization, prioritization, and follow-through.
• Regulatory writing and editing: Strong writing and editing skills, including the ability to translate technical/operational input into clear, accurate narratives and supporting materials for regulatory submissions and internal briefings.
• Analytical rigor and gap identification: Strong analytical skills to interpret requirements, synthesize information, validate supporting details, and identify gaps, risks, and decision points for escalation.
• Facilitation and coordination: Effective meeting facilitation and coordination skills (agendas, minutes, action-item tracking) to keep cross-functional work moving in a matrixed environment.
• Documentation and quality control: High attention to detail, including document management, version control, and maintenance of complete and defensible files for submissions and reporting.
• Relationship management (supporting external engagement): Strong interpersonal skills and ability to build productive relationships with internal partners and, as directed, support external stakeholder interactions; ability to influence without direct authority.
• Judgment and discretion: Sound judgment and discretion in handling sensitive, confidential, or politically complex matters; ability to escalate appropriately and maintain professionalism under pressure.
• Tools and trackers: Proficiency with common office and collaboration tools (e.g., Word, Excel, PowerPoint, SharePoint/Teams or similar) and comfort working with structured trackers and reporting templates.

Minimum Job Qualifications:

• Bachelor’s degree required in p ublic policy, public health, health care administration, business administration, political science, legal studies, or related. Master’s Degree preferred.
• Minimum of 5 years of progressive experience in regulatory affairs, health policy, healthcare administration, compliance/policy support, government relations support, or related work in a regulated healthcare environment.

License/Certification/Registration Required:

Supervisory Responsibilities:

None

Patient Contact:

None

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).