Rhythm Pharmaceuticals Inc. · 9 hours ago
Associate Director, Regulatory Operations
Boston, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$160K/yr - $240K/yr
8+ years expRhythm Pharmaceuticals Inc. is a global biopharmaceutical company focused on transforming the lives of patients with rare neuroendocrine diseases. The Associate Director of Regulatory Operations is responsible for managing regulatory submission standards, preparing eCTD submission-ready documents, and ensuring adherence to regulatory guidelines while collaborating with cross-functional teams.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Manage regulatory operations activities, ensuring timely and accurate regulatory submissions, and collaborating with cross-functional teams for our US, EU, UK and Health Canada regions
Identify/address opportunities to enhance operational effectiveness and drive process improvements within the department
Manage regulatory operations activities, including preparation of eCTD submission-ready documents, coordination across functions, and adherence to regulatory guidelines and processes
Support development program projects by collaborating with multi-disciplinary project teams to ensure successful program deliverables
Assist in the development of Standard Operating Procedures (SOPs) quality assurance, and records management practices related to regulatory operations activities
Track regulatory department information such as commitments with health authorities and NDA/IND commitments
Act as an expert resource for eCTD submissions to FDA, ensuring compliance with internal and health authority standards
Support the development and maintenance of operations resources for submission documents
Identify new or revised regulatory policies and initiate activities to support compliance
Participate in special projects and process improvement initiatives
Qualification
Required
Bachelor's degree in life/physical sciences or related field
8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations
Knowledge and understanding of the drug development process
Strong knowledge of FDA and Global EU/UK regulations and guidelines, especially CTD and eCTD structure
Experience with Veeva RIM EDMS
Highly proficient in Microsoft Office suite
Ability to balance both strategic and operational approaches, 'think outside the box' and to manage multiple tasks in a fast-paced environment
Detail-oriented and highly organized
Excellent interpersonal skills and ability to develop collaborative partnerships with key stakeholders
Benefits
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.
Company
Rhythm Pharmaceuticals Inc.
Rhythm Pharmaceuticals is a global, commercial-stage biopharmaceutical company focused on transforming the lives of patients with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.
201-500 employees
H1B Sponsorship
Rhythm Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (1)
2022 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.22BKey Investors
HealthCare Royalty PartnersMPM Capital,New Enterprise Associates
2025-07-10Post Ipo Equity· $175M
2024-04-01Post Ipo Debt· $150M
2022-09-14Post Ipo Equity· $124.8M
Leadership Team
Elisabeth Crönert-Bendell
SVP, Head of Strategy
Recent News
The Motley Fool
2026-02-02
2026-01-20
2026-01-11
Company data provided by crunchbase