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Associate Director, Regulatory Affairs

Rhythm Pharmaceuticals

Boston, MA

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Best Practices, Biology, Biotech and Pharmaceutical, Communication Skills, Continuous Improvement, Cross-Functional, Decision Support, Disease, Drug Development, Establish Priorities, FDA (Food and Drug Administration), Healthcare Providers, ICH Regulations, Intelligence Gathering, International Health, Leadership, Legal, Medical Products, Patient Care, Pediatrics, Presentation/Verbal Skills, Process Improvement, Regulations, Regulatory Requirements, Regulatory Submissions, Small Company, Standard Operating Procedures (SOP), Team Lead/Manager, Time Management, Willing to Travel
LOCATION
Boston, MA
POSTED
1 day ago
Company Overview
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
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.

Responsibilities and Duties
Strategic Leadership
  • 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

Hands-On Execution
  • 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

Expertise and Innovation
  • 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.)

Systems and Standards
  • 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

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs.This role may involve some travel.

The expected salary range for this position is $160,000 - $240,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. 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.


More about Rhythm
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

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
 

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Rhythm Pharmaceuticals

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