EQRx is uniquely positioned to revolutionize how medicines are brought to patients through innovation and strategic collaboration across global healthcare systems—it’s an opportunity to make a real impact.Michael Doherty Chief Regulatory Affairs
Director, Regulatory Affairs CMC
EQRx believes responsibility can be revolutionary. Want to make a difference while advancing your career? Come join a team that is working towards our bold mission of developing innovative medicines at radically low prices to help people get the medicines they need.
What You'll Do
What You'll Do
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 Have
This 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.
Who You Are
You 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 principles
You have prior experience authoring complex technical documents, such as CTD Modules 2 and 3.
You 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 environment
You 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.
Are you bold enough?
Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let’s work together to change the world and bring affordable medicines to all patients.
We aren’t about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities. What does EQRx stand for?
Are you ready to make waves in the industry and change the tides?
It’s (mutually) beneficial.
You’re curious about what sets us apart from the rest. What do you get from working at EQRx?
So, let’s start big—working at EQRx means having the opportunity to change the world.
By joining a team that’s remaking medicine development from start to finish, you’re going to enjoy the daily rush of throwing caution to the wind and doing things differently by:
- Working with the smartest game-changers in the industry
- Cutting down the red tape of “the way things are done”
- Seeing and feeling the daily impact of your work
- Growing as a professional and a person
- Committing to neverending social responsibility
And, yes—we also have a killer list of things that’ll help you shine as part of the team.
But to us, these are just table stakes.
- 100% Medical, Dental, and Vision coverage
- Flexible Spending Account
- Health Reimbursement Account
- Free snacks and drinks
*As EQRx grows, please note that some of these are subject to change.
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50 Hampshire StreetTwo-hour street parking is available. There are also several parking garages in the surrounding area.
Cambridge, MA 02139