Senior Director, Regulatory Affairs

Company Overview

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Wave’s RNA medicines platform, PRISM®, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and common disorders. Its toolkit of RNA‑targeting modalities, including RNAi (SpiNA) and RNA editing (AIMers), provides Wave with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology.

Wave’s pipeline is focused on its obesity, alpha‑1 antitrypsin deficiency, and PNPLA3 I148M liver disease programs, and also includes clinical programs in Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing the company’s versatile RNA medicines platform. Driven by the calling to “Reimagine Possible,” Wave is leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

The Senior Director, Regulatory Affairs is responsible for developing and executing the global regulatory strategy for assigned programs. Reporting to the Vice President, Regulatory Affairs and Policy, this individual represents Regulatory Affairs in the setting of cross‑functional program teams and provides risk‑based strategic and tactical guidance to meet the corporate goals. This position will develop and advance organizational policies and procedures, while also monitoring changes in the regulatory environment that may impact current or future program objectives.

• BA/BS degree in life sciences, M.Sc. or Ph.D. as a plus
• At least 15+ years in the pharmaceutical industry, with a minimum of 6 years in regulatory affairs
• Well‑versed in regulatory strategy, and regulatory writing
• Experience as primary regulatory author for IND and CTA documents
• Experience in communicating regulatory strategy, submission documents and plans both internally and externally

• Lead the timely preparation, review, publishing and submission of documents to regulatory authorities, and maintain compliance with applicable regulatory requirements and best industry practices
• Provide strategic guidance and insightful interpretation of applicable global/regional regulations in support of regulatory milestones such as IND, CTA, NDA, MAA; regulatory agency interactions; etc
• For the products assigned, lead and/or co‑author the preparation of information packages for regulatory submissions; review these packages for conformance with established regulatory requirements and company standards
• Assess opportunities for expedited pathways, such as US Breakthrough Therapy Designation or Priority Medicines
• Effectively communicate with internal and external team members, senior leaders and key stakeholders on the status of risks and mitigation plans associated with regulatory milestones
• Coordinate with the appropriate in‑house stakeholders the preparation of responses to queries from regulatory authorities and ensure timely submission
• Ensure regulatory commitments are addressed diligently, within the required timeframe
• Support continuous improvement of existing department processes and strategies
• Keep abreast of regulatory guidance and technical/scientific developments relevant to projects. Contribute to commenting on draft regulations and assess future areas for influencing the regulatory environment

• Knowledgeable in ICH, FDA and EMA guidelines, and familiarity with GCP, GLP, GRP;
• Extensive experience in working with regulatory health authorities such as FDA, EMA, Health Canada across all phases of clinical development; orphan drug experience is a plus
• Sound understanding of the scientific principles underlying the regulatory requirements
• Strong knowledge of eCTD elements and structure and regulatory writing skills.
• Ability to work independently and thrive in a fast‑paced environment
• Attention to detail
• Team player with the ability to be a situational leader when required
• Strong analytical and strategic thinking skills.
• Project and submission management skills