Vice President, Regulatory Affairs
About The Position
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.
Requirements
- Bachelor’s degree required; advanced degree in a scientific, medical, or related field preferred.
- 15+ years of progressive Regulatory Affairs experience in the biopharmaceutical industry, including deep global regulatory expertise and demonstrated success leading in complex, multi-region environments.
- Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.
- Demonstrated ability to build and strengthen scalable systems, processes, and operating models that improve execution, compliance, visibility, and organizational effectiveness.
- Strong enterprise planning, governance, financial stewardship, and resource allocation capability, with experience leading annual and quarterly planning, budget oversight, workforce planning, and external spend management.
- Demonstrated success leading regulatory execution for commercial-stage products and development programs in the U.S. and international markets, while balancing pace, quality, compliance, and business priorities.
- Strong continuous improvement mindset with pragmatic risk management and problem-solving skills, including the ability to modernize ways of working, navigate ambiguity, and drive measurable progress.
- Strong people leadership, coaching, and talent development capabilities, with a track record of building engaged, accountable, and high-performing teams.
- Ability to thrive in a fast-paced environment while maintaining high standards of quality, compliance, and execution excellence.
- Commitment to patients, ethics, quality, compliance, and company values; rare disease and/or specialty biopharmaceutical experience strongly preferred.
Responsibilities
- 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 practices.
- Provide senior leadership with execution updates, risk assessments, and pragmatic recommendations.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
