Associate Director, Regulatory Affairs

1h1 hour ago

Rhythm Pharmaceuticals

Boston, US · Full-time · $160,000 – $240,000

About this role

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We are seeking an exceptional Global Regulatory Lead who embodies our values and thrives in a dynamic, fast-paced environment.

As Global Regulatory Lead, you will be the regulatory architect and executor for assigned programs, driving science-based strategies that deliver results. You will lead the planning, authoring, and submission of regulatory filings including INDs, CTAs, and briefing documents, and serve as primary liaison with FDA, EMA, and other agencies.

You will serve as the regulatory voice within cross-functional teams and contribute to Rhythm's overall regulatory vision. This is a hands-on role where you will ensure regulatory excellence from strategy through execution, not simply oversee.

For the right candidate, this role offers significant growth potential as you help shape the regulatory future of our rare disease programs. You will make a meaningful impact on patients' lives by bringing new medicines to previously untreatable or undertreated diseases.

Requirements

Deep understanding of US and EU regulatory requirements and global regulatory frameworks
Experience leading the preparation and submission of global regulatory filings (INDs, CTAs, marketing applications)
Strategic thinking ability to shape high-level regulatory vision while executing detailed, hands-on work
Ability to serve as the regulatory voice on cross-functional teams and influence program direction
Familiarity with rare disease regulatory pathways (orphan designation, breakthrough therapy, PRIME, etc.)
Strong analytical skills to interpret regulations and develop science-based strategies
Proven track record of liaising effectively with health authorities such as FDA and EMA

Responsibilities

Develop and execute comprehensive regulatory strategies for assigned programs that align with Rhythm's values and business objectives
Lead the planning, authoring, and submission of regulatory filings (INDs, CTAs, briefing documents, Pediatric Investigation Plans, responses to agency questions)
Serve as primary liaison with FDA, EMA, and other regulatory agencies for your programs
Serve as Global Regulatory Lead on cross-functional core teams, ensuring regulatory considerations shape program direction
Manage regulatory timelines and ensure all commitments are met with excellence
Identify opportunities to leverage rare disease regulatory pathways such as orphan designation, breakthrough therapy, and PRIME
Help build and refine departmental processes, SOPs, and best practices
Maintain deep knowledge of US, EU, and global regulations, staying ahead of changes that impact our programs