Executive Director, Regulatory CMC

Rhythm Pharmaceuticals • Boston, MA

2d • $230,000 - $330,000 • Hybrid

About The Position

The Executive Director, Regulatory CMC leads Rhythm’s integrated Regulatory CMC function, owns regulatory CMC product portfolio strategy, and serves on the Regulatory Affairs Leadership Team. The role partners with senior leaders in Technical Operations, Quality, and Regulatory to ensure timely development and delivery of science-based Quality documentation across the portfolio, from development through post-approval.

As the senior strategic leader for Regulatory CMC, this role provides enterprise-level leadership and guides pragmatic, science-based strategies and risk-based decisions. It represents Rhythm within the broader regulatory CMC and Quality communities and advances company priorities in the global regulatory environment. The position also evolves the function and team culture, develops talent and leadership capability, and adapts the team to Rhythm’s portfolio and business needs.

The position may be based at Rhythm’s Boston, Massachusetts corporate office, remotely in the United States, or in select European locations. Rhythm follows a hybrid-work model, and candidates must be willing and able to attend the Boston office in coordination with department and business needs. Some travel may be involved; remote employees are expected to travel to Boston on a reasonable basis. The expected salary range is $230,000–$330,000. A discretionary annual bonus may be available, and the role may be eligible for benefits and other compensation, such as restricted stock units.

Requirements

• Bachelor of Science or equivalent in a chemical, biological, or mechanical science; an advanced degree is preferred.
• Target of 20 or more years of biopharmaceutical or pharmaceutical industry experience and at least 15 years in Regulatory CMC; academic or other regulatory experience may be considered in lieu of Regulatory CMC experience.
• Prior managerial experience; target of 10 or more years leading global Regulatory CMC professionals or cross-functional teams, including experience building, leading, and developing teams.
• Prior experience as a research, manufacturing, or quality scientist within the biotechnology or pharmaceutical industry, with experience transferable to Regulatory CMC.
• Ability to influence complex cross-functional decisions, evaluate regulatory and enterprise risk, and align stakeholders around pragmatic, science-based recommendations.
• Recognized Regulatory CMC expertise in at least one ICH region, significant experience across major global markets, and demonstrated leadership of major global Regulatory CMC submissions from strategy through approval.
• Executive-level communication and influencing skills, including the ability to tailor complex scientific and regulatory messages to different audiences and negotiate effectively with health authorities.
• Demonstrated servant leadership and coaching, including a track record of developing talent, empowering leaders, and holding team members accountable for outcomes.
• Fluency in written and spoken English.
• Willingness and ability to attend the Boston office in coordination with department and business needs; remote-based employees are expected to travel to Boston on a reasonable basis.

Nice To Haves

• Advanced degree such as a PhD, MS, PharmD, or MBA.
• Experience across relevant modalities such as small molecules, biologics, vaccines, and/or devices.
• Prior medical device experience or expertise.
• Specific FDA experience.
• Experience transferable from academic or other regulatory work in lieu of Regulatory CMC experience.

Responsibilities

• Lead the Regulatory CMC function and set portfolio-wide priorities, providing strategic oversight of regulatory strategy, risk assessment, optionality, and outcomes; review and approve Regulatory CMC documentation at the appropriate senior level.
• Represent Regulatory CMC in governance forums, presenting relevant considerations, risk assessments and mitigations, recommendations, and perspectives to influence cross-functional portfolio decisions.
• Translate corporate, portfolio, and patient priorities into clear Regulatory CMC priorities, build business acumen across the team, and incorporate the patient perspective.
• Build and sustain relationships with internal and external stakeholders, contribute to regulatory landscape assessments, and advocate for Rhythm’s priorities with health authorities and industry associations.
• Anticipate and interpret changes in the global Regulatory CMC and Quality environment, particularly in ICH-related markets, and advise internal stakeholders on portfolio impacts, risks, and recommended actions.
• Provide senior Regulatory CMC leadership for key global health authority interactions, participate directly as needed, prepare team members, and ensure consistent Regulatory CMC positions across the portfolio.
• Build and develop a high-performing team through clear expectations, coaching, talent development, actionable feedback, and opportunities for team members to grow leadership and strategic capabilities in alignment with company values and leadership principles.
• Set a forward-looking vision for the function, including thoughtful adoption of automation, AI, and new ways of working to improve efficiency, strategic contribution, and team capabilities.
• Own functional resource planning, budget management, and capability planning, and ensure suitable processes, standards, training, and ways of working support the portfolio.
• Partner with Regulatory, Technical Operations, Quality, and other senior leaders to assess portfolio priorities, resource trade-offs, and CMC regulatory risks, and recommend paths that balance scientific rigor, regulatory requirements, development timelines, and patient needs.

Benefits

• A discretionary annual bonus may be available based on individual and company performance.
• The role may be eligible for benefits and other compensation, such as restricted stock units.

What This Job Offers

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