There is an incredible opportunity for innovation in the drug development process. We are reimagining what’s possible to build a more efficient and sustainable model.Christian Antoni, MD, PhD Chief Global Development Officer
Director/ Senior Director, Regulatory Operations Lead
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.
Who We Are:
We're a new kind of biotech, one with a bold mission to bring innovative new medicines at dramatically lower costs.
What You'll Do:
As a Director/ Senior Director of Regulatory Operations, you’ll play a key role in our highly dynamic organization. You will build and manage a Best-in-Class Regulatory Operations team and will lead this team in developing and executing EQRx’s global electronic submission strategy and implementation. You will have the unique opportunity to grow and shape the Regulatory Affairs function of a rapid-growth company.
You will provide expert vision on regulatory informatics & submissions, including a strategic development plan for configuring, validating, and implementing electronic document management and publishing systems to support global regulatory authority requirements. (make this next sentence below part of the paragraph please)You’ll work closely with our partners and contracted vendors in ensuring the highest quality regulatory submissions and keeping to established timelines.
You will develop and manage an end-to-end submission process to support the Regulatory Operations organization, with the goal to provide strategic and operational excellence to ensure high quality and timely regulatory documentation, submissions and archiving across the product lifecycle. (make this next sentence below part of the paragraph please)
You’ll maintain a strategic and forward-thinking approach to achieving global consistency in regulatory standards and compliance aligned with the company’s business objectives. This role serves as (include with below sentence in one paragraph please)
a key interface and strong collaborator with our Regulatory and Informatics teams, as well as cross-functional stakeholders to ensure the business processes developed for submission management are seamlessly integrated with other electronic systems.
The Impact You Will Have:
This is not your standard Regulatory Operations 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 Professional Superpowers
- You have a bachelor’s degree
- You have 10+ years of related pharmaceutical/biotechnology industry experience, with 7+ years within Regulatory Operations and a thorough understanding of process and technology solutions.
- You’ve supported at least one successful major electronic application (NDA, BLA, MAA, JNDA, etc.).
- You have successfully led the implementation of Veeva RIM in an organization that has embraced the Veeva Platform as the master document management system, where cross functional system alignment is essential.
- You are a strategically oriented leader who takes pride building processes in a way that meaningfully impacts our business; you understand the importance of collaboration with Informatics and other business system owners across the organization.
- You endeavor to interface with relevant associations and external groups to increase the company’s ability to influence a changing regulatory informatics environment.
- You can thrive in a smaller company environment and love the pace of a fast-growing company.
- You understand relationships are key and have strong interpersonal skills.
- You can work both independently with minimal direction and collaboratively. within the Regulatory Affairs team and across multi-stakeholder teams.
- You’re a leader and a team player who is willing to roll-up your sleeves and get the job done.
- You can work effectively on multiple global programs in a fast-paced environment.
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.
Are you ready to fight for enduring patient access?
- Problem Solving
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.
Stay in the Loop
Follow us on social.
We’re Remaking Medicine in a virtual-first environment. You can also find us at our Cambridge Hub.
EQRx Hub Location
50 Hampshire Street
Cambridge, MA 02139
Phone +1 (617) 315-2255