Associate Director, Regulatory Affairs

Rhythm Pharmaceuticals • Boston, MA

1d • $160,000 - $240,000 • Hybrid

About The Position

Rhythm Pharmaceuticals is seeking an exceptional Global Regulatory Lead who embodies our organizational values and thrives in a dynamic, fast-paced environment. This is a rare opportunity for a strategic thinker who can see the forest and the trees, someone equally comfortable shaping high-level regulatory vision and rolling up their sleeves to execute the details that matter. As Global Regulatory Lead, you'll be the regulatory architect and executor for your assigned programs, driving science-based strategies that deliver results and support our mission. You'll serve as the regulatory voice within cross-functional teams, the primary interface with global health authorities, and a key contributor to Rhythm's overall regulatory vision. This isn't a role where you simply oversee—you'll be hands-on, ensuring regulatory excellence from strategy through execution. For the right candidate, this role offers significant growth potential as you help shape the regulatory future of our rare disease programs and make a meaningful impact on patients' lives.

Requirements

• Bachelor's degree in life sciences (graduate degree preferred)
• 8+ years of regulatory affairs experience in pharmaceutical/biotech drug development, including first-in-human studies and multiple development phases
• Proven expertise with rare disease regulatory programs (orphan products, fast track, breakthrough therapy, PRIME)
• Strong FDA experience and knowledge of ICH regulatory requirements across regions
• Experience in both large and small company settings (understanding different operational models and adapting accordingly)
• Strategic yet hands-on: You can architect the plan and execute the details with equal skill
• Nimble and adaptable: You pivot quickly when priorities shift and new information emerges
• Solution-oriented: You approach challenges with creativity and determination
• Values-aligned: You're driven by impact and committed to bringing therapies to underserved patient populations
• Independent and accountable: You set priorities, work autonomously, and deliver on commitments
• Excellent communicator: You translate complex regulatory concepts for diverse audiences

Nice To Haves

• Experience with EMA and other regional regulatory authorities
• Track record of success in rare disease regulatory strategy

Responsibilities

• Develop and execute comprehensive regulatory strategies for assigned programs that align with Rhythm's values and business objectives
• Contribute to company-wide regulatory strategy, bringing big-picture thinking and practical solutions
• Serve as Global Regulatory Lead on cross-functional core teams, ensuring regulatory considerations shape program direction
• Lead the planning, authoring, and submission of regulatory filings (INDs, CTAs, briefing documents, Pediatric Investigation Plans, responses to agency questions, and more)
• Manage regulatory timelines and ensure all commitments are met with excellence
• Serve as primary liaison with FDA, EMA, and other regulatory agencies for your programs
• Maintain deep knowledge of US, EU, and global regulations, staying ahead of changes that impact our programs
• Educate and guide cross-functional teams on regulatory requirements and opportunities
• Identify opportunities to leverage rare disease regulatory pathways (orphan designation, breakthrough therapy, PRIME, etc.)
• Help build and refine departmental processes, SOPs, and best practices
• Drive continuous improvement in how we approach regulatory challenges
• Conduct literature searches and gather intelligence to support strategic decision-making

Benefits

• Discretionary annual bonus may be available based on individual and company performance
• May be eligible for benefits and other compensation such as restricted stock units

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level