Wave Life Sciences

Senior Director, Regulatory Affairs CMC

Wave Life Sciences, MA, United States

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Job Description
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 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 recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.

Seniority level

Seniority level
Director

Employment type

Employment type
Full-time

Job function

Job function
Legal

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