Rhythm Pharmaceuticals Inc. · 1 day ago
Global Regulatory Lead
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$182K/yr - $275K/yr
10+ years expRhythm Pharmaceuticals Inc. is a global, commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with rare neuroendocrine diseases. The Global Regulatory Lead will create and execute regulatory strategies, ensuring compliance with global standards and managing regulatory initiatives for assigned programs.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Act as the Global Regulatory Lead within the cross-functional core team
Contribute to Rhythm’s overarching global regulatory strategy across programs
Develop regulatory development plans for assigned projects and oversee regulatory timelines
Take charge of planning and drafting content for submissions to Regulatory Agencies (such as INDs, CTAs, meeting requests, briefing documents, Pediatric Investigation Plans, and annual reports), and coordinate responses to regulatory inquiries
Serve as the primary liaison between the company and Regulatory Agencies for designated projects
Ensure regulatory filings are completed efficiently, on time, and in accordance with applicable standards and commitments
Expand and maintain expertise regarding US, EU, and ROW regulations relevant to assigned programs
Keep cross-functional team members informed about new regulations, standards, policies, and guidance from Regulatory Agencies that could impact the company
Conduct literature searches, prepare reports, and gather documentation to support project teams when needed
Assist in developing and updating departmental procedures, policies, SOPs, and related documents
Participate in efforts focused on improving internal standards and systems
Qualification
Required
Bachelor of Science (BS) degree required
At least 10 years of regulatory affairs experience in drug development within the pharmaceutical or biotechnology industry. Experience should include work across multiple phases of development and ideally encompass both large and small company environments
Demonstrated expertise with regulatory programs for products addressing rare diseases and/or unmet medical needs—such as orphan products, fast track, breakthrough therapies, or PRIME designations—is required
Strong experience with the U.S. Food and Drug Administration (FDA) is essential
Full functional knowledge of regulatory requirements—including regulations, directives, and guidance/guidelines—pertaining to the development and registration of drug products in multiple International Council for Harmonisation (ICH) regions is essential
The ideal candidate will be able to set priorities, work independently, and deliver results within established timelines
Strong organizational and planning skills are necessary, along with the ability to communicate effectively and efficiently with multiple audiences
Preferred
Graduate degree is preferred
Experience working with the European Medicines Agency (EMA) or other regional regulatory bodies is preferred
The role requires evidence of critical strategic thinking and a solution-oriented approach, with the ability to think creatively. Preference will be given to individuals who can demonstrate these skills within rare disease programs
Benefits
A discretionary annual bonus may be available based on individual and company performance.
This role may be eligible for benefits and other compensation such as restricted stock units.
Company
Rhythm Pharmaceuticals Inc.
Rhythm Pharmaceuticals is a global, commercial-stage biopharmaceutical company focused on transforming the lives of patients with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.
201-500 employees
H1B Sponsorship
Rhythm Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (1)
2022 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.22BKey Investors
HealthCare Royalty Partners
2025-07-10Post Ipo Equity· $175M
2024-04-01Post Ipo Debt· $150M
2022-09-14Post Ipo Equity· $124.8M
Leadership Team
Elisabeth Crönert-Bendell
SVP, Head of Strategy
Recent News
Investor's Business Daily
2025-12-12
Company data provided by crunchbase