Overview

Job OpportunitiesWave 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, and obesity. 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.Role OverviewThis role will support and lead activities within the Regulatory group to advance development of the assets in Wave's pipeline to registration and launch; will collaborate closely with team members within the group and across drug development disciplines such as CMC, Nonclinical, Clinical and Quality. This position will be a hybrid position in Lexington, MA OR remote in the UK.ExperienceBA/BS degree in life sciences, MS preferredAt least 8-12 years of pharmaceutical product developmentResponsibilitiesDeliver on the strategic direction for the assigned development programs including the preparation of clinical trial applications to support the execution of the clinical development plan; provide guidance to and collaborate with the relevant subject matter experts to ensure timely execution of regulatory milestonesPromptly identify and communicate regulatory risk areas and develop mitigation and/or contingency plans; assess the need for revision of the regulatory strategy or tacticsLead and support preparation of high-quality global regulatory submissions compliant with applicable requirements to meet the corporate goalsEnsure consistency, completeness and adherence to standards for all regulatory submissionsMonitor and analyze the continuously evolving regulatory environment to identify changes in regulations and guidelines, new initiatives, etc. Assess their impact and communicate to program teams.Participate in the development and review of standard operating procedures to ensure compliance with current regulatory requirementsAssist with regulatory agency inspections; monitor external consultantsKey SkillsWell-versed in regulatory strategy, and regulatory writingExperience as primary regulatory author for IND and CTA documents; experience with EU CTR would be beneficial.Knowledgeable in ICH, FDA and EMA guidelinesKnowledge of eCTD structureCritical thinking and problem-solvingAbility to work independently and thrive in a fast-paced environmentAttention to detailExcellent communication skillsWave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge.We value our relationships with professional recruitme