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Vice President, Regulatory Affairs

Rhythm Pharmaceuticals

Boston, MAStaff$260k – $360k/yr
Sign in to applyVerified 1h ago
Location
Boston, MA
Work model
On-Site
Level
Staff
Salary
$260k – $360k/yr

About this role

Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. 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 The Vice President, Regulatory Affairs is a senior leader within Rhythm’s Global Regulatory Affairs organization and will play a key role in strengthening the operating model for the company’s next phase of growth. This role translates regulatory strategy into disciplined execution and ensures the systems, processes, governance, and talent are in place to deliver fast, scalable, high-quality global regulatory outcomes. This leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. The successful candidate will elevate execution, strengthen planning and governance, and build the capability needed to operate with greater speed, rigor, and consistency in an increasingly complex global environment. Rhythm is at an important inflection point, with portfolio growth and increasing global complexity requiring a step change in how Regulatory Affairs operates. This role is critical to modernizing the operating model and building the capability needed to deliver faster, more scalable regulatory execution in support of patient access and long-term growth. The ideal candidate brings deep global regulatory expertise, a track record of leading through growth and complexity, and the presence to strengthen infrastructure, raise performance standards, and drive transformation in a commercial-stage biopharmaceutical environment. Responsibilities and Duties Lead key regulatory sub-functions composed of experienced team leaders and subject matter experts, ensuring alignment, accountability, and execution at scale. Partner with the Head of Global Regulatory Strategy to translate regulatory strategy into execution priorities, operating plans, governance, and measurable outcomes. Partner with the Chief Regulatory Officer and Global Regulatory Leads to align resources, capabilities, and execution with regulatory and business priorities. Strengthen the systems, processes, and infrastructure needed for faster, scalable, and compliant regulatory execution. Drive operational excellence across planning, governance, submission readiness, compliance, and inspection support. In partnership with the IT Business Partner, advance the use of artificial intelligence and digital tools to improve productivity, compliance, transparency, and decision-making. Oversee execution of global regulatory plans for marketed products, lifecycle management programs, and development-stage assets. Support new market entry and global expansion through strong operational readiness. Provide leadership across international regulatory execution, CMC regulatory, labeling, and regulatory operations. Support regulatory business operations, including annual and quarterly financial planning and budget oversight, workforce and resource planning, and contracting and purchase order activities in support of portfolio and enterprise growth. Promote continuous learning and capability building across the regulatory organization. Partner cross-functionally to align regulatory execution with enterprise priorities, timelines, and launch objectives. Anticipate evolving global regulatory requirements and embed them into processes, submissions, and operating

Vice President, Regulatory Affairs at Rhythm Pharmaceuticals, Boston, MA | Yoinka