Senior 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, 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.

 

 

Description: 

 

The Senior Director, Regulatory Affairs CMC is responsible for developing and executing global regulatory CMC strategies for programs in Wave’s pipeline. Reporting to the VP, Regulatory Affairs and Policy, this individual is responsible for leading and contributing to the preparation of CMC regulatory information packages for global submissions. The Senior Director, Regulatory Affairs CMC ensures compliance with applicable regulatory CMC requirements and company standards. The ideal candidate will develop and advance organizational policies and procedures, while also anticipating regulatory obstacles and risks/emerging issues that may impact current or future plans. This is a hybrid position located in Lexington, MA.

 

Experience: 

 

• BA/BS degree in life sciences, M.Sc. or Ph.D. is a plus
• Minimum of 15 years of experience within the pharmaceutical industry, of which a minimum of 8 in Regulatory Affairs CMC
• Line management experience preferred
• Experience with RNA medicines preferred

 

Responsibilities:

 

• Ensure the development of robust, global regulatory CMC strategies designed to meet program goals for the Wave programs
• Work closely with the Regulatory Strategy Lead(s) to ensure an integrated global regulatory strategy for the programs. Develop submission plans and timelines in accordance with project goals
• Develop and/or author CMC content and deliver high quality information packages in support of INDs and NDA (Module 3, 2.3), CTA (IMPD) and equivalent submissions, as applicable 
• Direct subject matter experts in content development and authoring, as needed and identify potential gaps, risks, and mitigation measures
• Inform and consult with the line manager on any major issues for the projects including any changes to plans or emerging risks
• Triage and coordinate rapid responses to questions from regulatory authorities globally 
• Provide regulatory expertise for the assessment of CMC change controls/deviations/CAPA
• Contribute to initiatives to improve processes within the Regulatory department
• Keep abreast of regulatory guidance and technical/scientific developments relevant to programs
• Support VP, Regulatory, Policy and Compliance in resourcing discussions to ensure projects are resourced appropriately with regards CMC aspects. Where appropriate, manage external consultants ensuring the work is completed on time and to a high quality
• Line manage/mentor less experienced CMC regulatory team members as appropriate

 

Key Skills: 

 

• Application of US/EU regulatory CMC requirements for early-stage development and stage appropriate development consideration throughout product lifecycle (such as development of Phase 1 appropriate manufacturing dossier)
• Regulatory strategy development to advance drug development through registration, including experience in new IND/EU CTA workplan and submission strategy, document development, breakthrough designation and/or PRIME request package and associated meeting materials, global NDA submission plan and Module 3 development strategy
• Project management of complex regulatory submissions (e.g.  new IND, new CTA) including application of content knowledge under FDC&A and European Directives
• Drafting and preparation of regulatory submissions for therapeutics candidates in accordance with ICH, FDA and EMA guidelines
• Applying eCTD structure to performing IND/CTA/NDA life-cycle management including de novo applications, scale-up/comparability protocols and associated manufacturing process change amendments

 

 

 

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for em