Wave Life Sciences · 2 hours ago
Senior Director/Director, Regulatory Operations
Lexington, MA, United States
Full-time
Onsite
Director/Executive
12+ years expWave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. The Senior Director/Director, Regulatory Operations is responsible for ensuring timely and compliant global regulatory submissions, collaborating with Regulatory Leads, and establishing best practices in Regulatory Operations.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Ensure the appropriate collaboration with the Regulatory Strategy Leads, plan for and timely deliver regulatory documents compliant with eCTD publishing standards
Proactively, and in collaboration with the Vice President, Regulatory and Policy, identify the need for, engage and oversee contract Regulatory Operations resources; support Vice President, Regulatory and Policy, in budget discussions pertaining to Regulatory Operations Resource
Ensure the quality of document-level publishing of CTA, IND, and other regulatory submissions
Manage vendors to ensure quality and on-target delivery of planned electronic submissions to regulatory bodies
Proactively identify new platforms that would better address immediate Regulatory Operations needs and mid- to long-term strategies collaborating appropriately with in-house and/or external IT experts
Ensure the optimization of the existing Regulatory Information Management system in support of day-to-day Regulatory Operations activities
Ensure appropriate archiving of regulatory packages submitted and competent authority correspondence or queries received
Assess Regulatory Operations process gaps; improve existing processes; develop and implement new processes to track performance and progress against priorities of the Regulatory Affairs function
Ensure that Regulatory Operations practices are consistent with the latest competent authority and industry publishing, submission and archiving standards
Monitor changes of regulatory requirements in ICH regions related to eCTD submission formats or standards; interpret these requirements and inform the organization; propose the necessary measures to implement
Ensure Regulatory Operations assists Medical and Regulatory Writing with document versioning, electronic storage and archiving
Provide support during inspections; assist with due diligence required by Wave’s corporate partners
Ensure Regulatory Operations collaborates with the TMF specialist and CRO to provide the regulatory components of the TMF; support TMF maintenance
As a global submissions expert, ensure the project teams have sufficient awareness and knowledge of e-submissions (eCTD, NeeS, etc.) and lifecycle management concepts and communicate regional differences as appropriate within the context of global submission preparation
Qualification
Required
At a minimum, a B.A./B.S. degree in a scientific discipline; PhD/PharmD/M.Sc. in life sciences is a plus; equivalent experience may be accepted
12-15 years of relevant industry experience, 6+ years in a regulatory operations management role
Knowledge of leading a regulatory operations function desired
Experience working with/coordinating with external contractors/consultants
Technical expertise in Microsoft Word, Adobe Acrobat, and regulatory submission publishing and electronic document management systems
Excellent writing and communication skills
Strong interpersonal skills; a team player
Flexibility to function well within a team environment and within condensed timelines
Strong project management and organizational skills
Understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
Ability to comply with company and/or industry style guides and templates
Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy
Company
Wave Life Sciences
Wave Life Sciences is a clinical-stage RNA medicines company committed to delivering life-changing treatments for people battling diseases
201-500 employees
H1B Sponsorship
Wave Life Sciences 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 (15)
2024 (11)
2023 (15)
2022 (16)
2021 (15)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$1.22BKey Investors
GlaxoSmithKlineTakeda VenturesForesite Capital
2025-12-09Post Ipo Equity· $350M
2024-09-24Post Ipo Equity· $200M
2023-12-06Post Ipo Equity· $100M
Leadership Team
Paul Bolno
President and CEO
C
Chandra Vargeese
Chief Technology Officer and Head of Platform Discovery Sciences
Recent News
2026-01-06
2026-01-05
Company data provided by crunchbase