Associate Director, Regulatory Affairs

Responsibilities and Duties

• 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

Qualifications and Skills

• Required Experience:
• 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)
• Essential Qualities:
• 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
• Preferred:
• Experience with EMA and other regional regulatory authorities
• Track record of success in rare disease regulatory strategy