Global Regulatory Lead
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
In this pivotal position, the individual will lead the creation and execution of regulatory strategies that are grounded in scientific principles, focused on providing effective solutions, and aligned with internal objectives for the designated program(s). The role encompasses overall accountability for shaping and steering regulatory direction to support program success. As the Global Regulatory Lead, you will oversee your assigned programs, ensuring regulatory initiatives are managed efficiently and submissions are executed on schedule. This responsibility includes upholding compliance with global regulatory standards and fulfilling all regulatory commitments. You will provide expert regulatory oversight and guidance, working to enhance internal standards and systems. Your input will be essential in advising and supporting internal stakeholders with both technical and procedural regulatory strategies, thereby advancing the development, commercialization, and life cycle management of Rhythm products. Responsibilities and Duties
- 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.
- Bachelor of Science (BS) degree required, and graduate degree is preferred.
- 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. 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.
- 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. They should also possess the ability to adapt and respond to new information or changing priorities as needed.
- Strong organizational and planning skills are necessary, along with the ability to communicate effectively and efficiently with multiple audiences.
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
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