Associate Director, Regulatory Affairs CMC

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 preclinical program in 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.

Job Summary:
The Associate Director, Regulatory Affairs CMC will develop and execute global regulatory CMC strategies to support drug development programs across all phases of the product lifecycle, from IND/IMPD through NDA/MAA submissions and post-approval changes. This role requires deep expertise in authoring, reviewing, and coordinating high-quality CMC regulatory documentation for global submissions, managing responses to health authority questions, and supporting cross-functional teams in the preparation and submission of regulatory dossiers.

Reporting to the Director, Regulatory Affairs, the Associate Director will provide strategic oversight, ensure compliance with global regulatory requirements, and actively contribute to the improvement of regulatory processes. Candidates with strong manufacturing process knowledge and hands-on experience with technical data are highly preferred. Oligonucleotides experience is a plus.

Job Description:

Strategic Leadership:

• Assist in developing and implementation of robust, global regulatory CMC strategies to meet program objectives across early- and late-stage development
• Anticipate regulatory risks and emerging issues, proposing mitigation plans and solutions

CMC Document Preparation and Management:

• Author and review high-quality CMC sections (e.g., Module 3, 2.3) for INDs, IMPDs, CTAs, NDAs, and MAAs, ensuring compliance with ICH, FDA, EMA, and other global regulatory requirements
• Summarize technical data (e.g., method validation, batch analysis, stability studies, process descriptions) into concise regulatory documents, ensuring alignment with source documentation
• Support SMEs by interpreting technical reports and converting them into regulatory-compliant documentation.
• Support the review and approval of technical source reports to be used for regulatory submissions, ensuring a first pass review of process documents from a regulatory perspective.
• Support tech transfer and comparability protocol development between manufacturing phases and sites.

Collaboration and Oversight:

• Partner with cross-functional teams (e.g., Process Development, Analytical Development, Manufacturing, and Quality) to ensure timely submission of high-quality CMC deliverables
• Liase with clinical regulatory lead and ensure CMC strategy is cohesively built in the overall development strategy
• Coordinate with external partners (e.g., CMOs, CROs, and publishing vendors) to align submission timelines and deliverables

Health Authority Interactions:

• Lead the preparation of responses to health authority queries on CMC-related aspects in a timely and strategic manner
• Prepare FDA briefing documents, meeting requests, and submissions in alignment with regulatory guidelines
• Represent CMC in cross-functional meetings with health authorities and external stakeholders

Compliance and Lifecycle Management:

• Maintain submission trackers and ensure the timely update of regulatory documentation
• Manage lifecycle submissions, including IMPD/IND amendments, change controls, and post-approval commitments, ensuring all regulatory requirements are met

Process Improvement:

• Contribute to the development and refinement of internal policies, procedures, and best practices within the Regulatory Affairs department
• Keep abreast of industry trends, emerging regulatory guidance, and updates to global requirements, ensuring continuous improvement and compliance

Key Skills and Qualifications:

Educational Background:

• Bachelor's degree in Life Sciences required; advanced degree (M.Sc. or Ph.D.) preferred

Experience:

• A minimum of 8 years of experience in the pharmaceutical or biotechnology industry, with at least 6 years in Regulatory Affairs CMC
• Hands-on experience with IND, CTA, and NDA/MAA submissions, including Module 3 authoring and lifecycle management
• Proven track record of working on U.S., EU, and Canada submissions

Technical Expertise:

• Strong understanding of global regulatory CMC requirements, including ICH guidelines and FDA/EMA/ROW-specific expectations
• Familiarity with technical data, including but not limited to method validation, stability studies, and manufacturing process descriptions
• Experience authoring FDA/ EU briefing documents and responding to health authority queries

Project Management and Communication Skills:

• Proven ability to manage complex regulatory projects across cross-functional teams and external partners
• Exceptional organizational and communication skills to liaise effectively with internal and external stakeholders

Regulatory Tools and Systems:

• Expertise with regulatory tools such as Veeva Vault, SharePoint, and Excel trackers and PowerPoints