Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. 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
Reporting to the Director, IT Business Partner, R&D, this role will serve as the primary IT Business Analyst for Regulatory Affairs. The analyst will translate Regulatory business needs into scalable technology, data, and process solutions. The role will support the lifecycle of Regulatory applications and initiatives, including discovery, requirements, process design, implementation, validation, adoption, operational support, and continuous improvement in a global biopharmaceutical environment. This role combines business partnership with hands-on business analysis, solution delivery, and application support, working closely with Regulatory stakeholders, Quality, IT colleagues, and external vendors.

Responsibilities and Duties
Business Partnership & Process Improvement

Build strong partnerships with Regulatory Affairs, Regulatory Operations, Regulatory CMC, Labeling, Medical Writing, Quality, and other R&D stakeholders to understand goals, pain points, risks, and priorities and serve as a technology subject-matter resource for assigned systems and processes.
Conduct discovery through interviews, workshops, document analysis, process observation, and data review; translate findings into business and functional requirements, user stories, acceptance criteria, and process flows.
Map current-state and future-state regulatory processes, identify control gaps and inefficiencies, and support the development of practical, scalable improvements in partnership with business process owners.
Partner with stakeholders and the Director, IT Business Parter R&D, to assess business demand, enhancements, and project opportunities and provide input into prioritization based on business value, risk, urgency, and available resources.
Support the technology and information-management needs associated with global regulatory planning, registration strategies, health authority interactions, and post-approval commitments.

Solution Delivery & Application Management

Support Regulatory Information Management capabilities, including registration data, submission planning and tracking, health authority correspondence, commitments, Labeling management, product and dossier information, publishing handoffs, and regulatory intelligence use cases.
Partner with business and technical teams to expand adoption and harmonize processes for Veeva RIM or comparable regulatory platforms.
Support integrations, data migration, master data, reporting, dashboards, periodic submission tracking, notifications, and controlled document exchanges across regulatory and enterprise platforms.
Coordinate requirements traceability, test strategy, test scripts, user acceptance testing, defect triage, release readiness, training, and user documentation for assigned initiatives.
Coordinate application support, issue resolution, root-cause analysis, enhancement intake, release planning, and vendor performance for assigned systems.

Governance, Compliance, & Operational Support

Ensure projects and changes follow applicable IT lifecycle, change control, validation, security, privacy, data integrity, records management, and GxP procedures.
Partner with Regulatory Affairs, Quality, and IT stakeholders to maintain assigned regulatory systems, processes, and records in an inspection-ready state
Develop business cases, scope documents, decision papers, roadmap inputs, RAID logs, governance materials, operating procedures, and support documentation.
Communicate dependencies, status, decisions, and risks to cross-functional teams and senior leadership.
Contribute to the R&D technology roadmap and support the evaluation of automation, analytics, workflow, and responsible AI opportunities for Regulatory Affairs.

Qualifications and Skills

Bachelor’s degree in information systems, computer science, life sciences, or a related field, or equivalent practical experience.
5+ years of progressively responsible business analysis, product ownership, application management, or technology delivery experience in a life-sciences or biopharmaceutical environment.
Experience supporting Regulatory Affairs processes and applications in pharmaceutical, biotechnology, medical device, or another regulated life-sciences environment.
Working knowledge of regulatory submission planning, content coordination, publishing handoffs, filing, tracking, archival, and post-submission lifecycle activities.
Experience with regulatory information management processes involving products, registrations, applications, commitments, correspondence, labeling and controlled vocabularies.
Strong elicitation, process mapping, requirements, testing, documentation, analytical, facilitation, and stakeholder-management skills.
Demonstrated ability to manage competing priorities, work independently within established direction, influence outcomes, and contribute hands-on when needed.
Excellent written and verbal communication skills with a strong customer-service, technology advisory, and partnership mindset.
Hands-on Veeva Vault RIM implementation, expansion, migration, or operational support experience.
Knowledge of GxP computerized system validation, 21 CFR Part 11, electronic records controls, audit readiness, and data integrity principles.
Experience supporting validated applications, including testing, role-based security, audit trails, change control, or other regulated-system controls.

Preferred Qualifications

Experience with Veeva Quality or comparable QMS, validated SaaS platforms, Microsoft 365, SharePoint, Smartsheet, reporting tools, APIs, and secure file-transfer patterns.
Experience with submission lifecycle, publishing, IDMP or structured data concepts, labeling, regulatory intelligence, or regulatory CMC.
Experience managing SaaS vendors, implementation partners, support SLAs, releases, and enhancement backlogs.
CBAP, PMI-PBA, CSPO, PMP, Agile, Veeva, or relevant life-sciences technology certification.
Experience with Veeva Vault RIM suite or comparable RIM platforms; experience with Registrations, Submissions, Submissions Archive, or Publishing.
Experience with electronic document and content management, structured content, submission publishing, regulatory intelligence, and health authority gateway solutions.
Experience with health authority interactions, requests for information, response tracking, and inspection-ready evidence.
Experience with one or more related areas such as Regulatory CMC, labeling, medical writing, document management, regulatory intelligence, and cross-functional dossier collaboration.
Experience with regulatory data governance, metadata, taxonomy, reporting, reconciliation, and integration between regulatory, quality, clinical, safety, and document platforms.
Experience supporting system integrations, data migration, role-based security, audit trails, dashboards, and vendor-hosted platforms.
Relevant business analysis, product ownership, project management, Agile, Veeva, or life-sciences technology certification.

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 $90,000 - $135,000. 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

Inherent in our core values is the commitment to act ethically and with integrity in all we do.

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.

About the company

Rhythm Pharmaceuticals develops and commercializes therapies for rare neuroendocrine and genetic obesity disorders. Its lead drug, IMCIVREE (setmelanotide), is an MC4R agonist that helps restore signaling in the melanocortin-4 pathway to regulate hunger and energy use. The company earns revenue primarily from global IMCIVREE sales and reinvests in research, development, and commercialization. Its aim is to broaden MC4R-targeted treatments for underserved patients and advance additional candidates like bivamelagon and RM-718 through clinical development.

Company Size

501-1,000

Company Stage

IPO

Headquarters

Boston, Massachusetts

Founded

2008

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Simplify's Take

What believers are saying

Second-quarter 2026 product revenue hit $71.3 million, up 19% sequentially.
More than 400 acquired-HO start forms came from roughly 300 prescribers by June 30, 2026.
AJ Joshi became chief medical officer on August 17, 2026, strengthening late-stage execution.

What critics are saying

Rhythm depends on IMCIVREE; August 2026 revenue still came entirely from one drug.
RM-718 and bivamelagon must succeed after 2026 data; failure leaves no next growth engine.
Hypothalamic obesity launches in Japan and Europe need reimbursement speed; delays hit 2027 demand.

What makes Rhythm Pharmaceuticals unique

Rhythm owns the only approved MC4R franchise for rare genetic obesity, built since 2008.
IMCIVREE won Japan MHLW approval on August 24, 2026, extending global rare-obesity reach.
Rhythm published a Bardet-Biedl diagnostic algorithm, improving patient identification for prescribers.

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Yahoo Finance

Oct 13th, 2026

Rhythm launches IMCIVREE in Japan, the first approved therapy for acquired hypothalamic obesity

Rhythm Pharmaceuticals has launched IMCIVREE (setmelanotide) in Japan to treat acquired hypothalamic obesity. It is the first approved therapy for the condition in the country, and it is now on Japan's National Health Insurance drug price list. Japan's Ministry of Health, Labour and Welfare approved the drug in August. The approval rested on the Phase 3 TRANSCEND trial of 142 patients, which met its primary endpoint with an 18.8% placebo-adjusted reduction in body mass index. Rhythm, based in Boston, estimates that 5,000 to 8,000 people in Japan live with the condition. "This launch marks an important advancement for people living with acquired HO in Japan," said Yann Mazabraud, executive vice president and head of international at Rhythm.

Yahoo Finance

Sep 12th, 2026

Druckenmiller's fund buys $22.6M stake in rare obesity treatment maker Rhythm Pharmaceuticals

Stanley Druckenmiller's Duquesne Family Office disclosed new positions in over 40 stocks in its second quarter 13F filing. Notable healthcare investments included 203,618 shares of Rhythm Pharmaceuticals worth $22.6 million and 356,600 shares of Definium Therapeutics worth $16.8 million. Rhythm Pharmaceuticals develops treatments for hypothalamic obesity, currently the only approved drug for this condition. The company estimates approximately 10,000 US patients have acquired hypothalamic obesity, with similar numbers in Europe and 5,000 to 8,000 in Japan. Second-quarter revenue increased 47% year over year, whilst US revenue jumped 38% sequentially. The company remains unprofitable despite revenue growth and held $330.9 million in cash at quarter end, expected to fund operations for at least 24 months.

Yahoo Finance

Aug 24th, 2026

Japan approves Imcivree for acquired hypothalamic obesity, launch expected by end of 2026

Rhythm Pharmaceuticals has received approval from Japan's Ministry of Health, Labour and Welfare for IMCIVREE (setmelanotide) to treat patients with acquired hypothalamic obesity (HO). This marks the first therapy approved in Japan for this condition. The approval was supported by the Phase 3 TRANSCEND trial involving 142 patients, including a Japanese cohort. The study met its primary endpoint with an 18.8% placebo-adjusted reduction in body mass index. Rhythm estimates 5,000 to 8,000 people are living with acquired HO in Japan. The company expects to launch IMCIVREE before the end of 2026, pending final pricing determination. Acquired HO is characterised by accelerated weight gain following hypothalamic injury, often resulting from craniopharyngioma, astrocytoma, or other hypothalamic-pituitary tumours.

Yahoo Finance

Aug 17th, 2026

Rhythm Pharmaceuticals appoints Manher Joshi as chief medical officer

Rhythm Pharmaceuticals has appointed Manher "AJ" Joshi as Chief Medical Officer, effective 17 August. Dr Joshi brings over 20 years of experience spanning drug discovery, pivotal trials, regulatory processes and lifecycle management. Dr Joshi joins from Soleno Therapeutics, where he served as Chief Development Officer. He previously held the Chief Medical Officer position at Neurona Therapeutics and executive roles at Atara Biotherapeutics. His career also includes leadership positions at Allergan Medical, Synageva BioPharma, and Genzyme. Rhythm is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases. Its lead asset, IMCIVREE (setmelanotide), is approved in the US and Europe for treating certain forms of obesity. The company is advancing next-generation MC4R agonists through late-stage development.

Associated Press

Aug 11th, 2026

Rhythm Pharmaceuticals' IMCIVREE receives UK approval for acquired hypothalamic obesity treatment

Rhythm Pharmaceuticals announced that the UK's Medicines and Healthcare products Regulatory Agency has expanded the marketing authorisation for IMCIVREE (setmelanotide) to include treatment of obesity and control of hunger in adults and children aged 4 and older with acquired hypothalamic obesity due to hypothalamic injury or impairment. The MHRA also granted IMCIVREE orphan drug designation for acquired HO. The approval is based on results from the Phase 3 TRANSCEND trial, which met its primary endpoint with a statistically significant 19.8% placebo-adjusted reduction in body mass index. The global trial enrolled 120 patients. IMCIVREE initially received marketing authorisation in the UK in 2021 for treatment of obesity in patients with POMC, PCSK1 or LEPR deficiency, with subsequent expansions for other rare obesity conditions.

Rhythm Pharmaceuticals

IT Business Analyst - Regulatory

About the job

About the company

Get referred to Rhythm Pharmaceuticals

Simplify's Take

What believers are saying

What critics are saying

What makes Rhythm Pharmaceuticals unique

Benefits

Growth & Insights and Company News

6 month growth

1 year growth

2 year growth