Senior Director/Director, Regulatory Operations

Wave Life Sciences•Lexington, MA

About The Position

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a clinical program in obesity and a preclinical program in NASH/MASH. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Description: The Senior Director/Director, Regulatory Operations is responsible for ensuring the publishing, electronic submission to health authorities, and archiving of all global regulatory submissions occurs in a timely and compliant manner. The ideal candidate will collaborate with the Regulatory Leads, to plan and prepare high quality global submissions, in-house and/or via CRO. This role will establish best Regulatory Operations practices, develop new procedures and work instructions, and assist in other activities, as needed. Experience: 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.

Requirements

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

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