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Director, Regulatory Affairs CMC

Company: EQRx
Location: Somerville
Posted on: October 8, 2020

Job Description:

As Director, Regulatory Affairs CMC you will play a key role in our highly dynamic organization. You will partner with EQRx’s Regulatory Affairs strategists to lead and execute global regulatory plans that expedite development, maximize the probability of success, and mitigate risks. You will have the unique opportunity to grow and shape the Regulatory function of a rapid-growth biotech startup.You will formulate and lead innovative CMC regulatory strategies for assigned development projects, represent Global Regulatory Affairs CMC on interdisciplinary project teams, and present comprehensive risk assessment and mitigation plans for potential regulatory issues to successfully influence key stakeholders. You will proactively identify the required documentation and any content, quality and/or timeliness considerations for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. You will lead the planning, authoring, and preparation of high-quality, eCTD-compliant CMC documentation for submission to global health authorities in support of regulatory filings, such as INDs, NDAs, MAAs, CTAs/IMPDs, amendments, annual updates, pre-meeting packages, and responses to Health Authority queries. You will serve as main point of contact and lead interactions with global Health Authorities for CMC-related topics and responses to requests for information. You will participate in the development and continuous improvement of processes, standards, and capability-building within EQRx’s Global Regulatory Affairs team. You will also maintain up-to-date knowledge of relevant CMC-related guidelines in key geographies and effectively communicate across the organization any impact on development programs in a timely manner. The Impact You Will HaveThis is not your standard Regulatory Affairs position. We are doing things different here than how it is normally done, and this role is no exception. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.Your SuperpowersYou have a bachelor’s degree in a relevant scientific discipline; MS/PhD preferred.You have 8+ years of related pharmaceutical/biotechnology industry Regulatory Affairs CMC experience.You have a comprehensive knowledge of CMC product development and an understanding of related pharmaceutical operations (e.g. manufacturing, formulation, process development, analytical, quality assurance)You have a proven command of ICH requirements, applicable GMP regulations and demonstrated knowledge and experience with implementation of QbD principlesYou have prior experience authoring complex technical documents, such as CTD Modules 2 and 3You have led successful interactions with global regulatory authorities on CMC-related issues.You can work both independently with minimal direction and collaboratively within the Regulatory Affairs team and multi-stakeholder project teams.You can work effectively on multiple global programs in a fast-paced environmentYou have the ability to clearly articulate regulatory positions to diverse audiences, including functional team members, company management, external vendors and global Health Authorities.You are a leader. Teams love working with you and you are someone who takes pride in mentoring and supporting the careers of others.You can thrive in a smaller company environment and love the pace of a true startup.You understand relationships are key and have strong interpersonal skills.You’re a team player who is willing to roll-up your sleeves and get the job done.EQRx is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.Cambridge, MA /Regulatory /Full-Time

Keywords: EQRx, Somerville , Director, Regulatory Affairs CMC, Other , Somerville, Massachusetts

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