Team Photograph: Photograph for Senior Manager Global Regulatory Affairs

We believe it’s possible to have a profound impact on bending the cost curve in healthcare by building a pipeline of innovative medicines and bringing them to market at dramatically lower prices.

Robert Forrester CXO

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.

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 Senior Manager, Global Regulatory Affairs you will play a key role in our highly dynamic organization. You will implement EQRx’s overall regulatory strategy for the business 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 be responsible for the coordination, preparation and review of regulatory submissions in support of global clinical trials. You will also be responsible for the preparation and assembly of documentation required for Health Authority interactions, Investigational New Drug Applications (IND), Clinical Trial Applications (CTA) for initial applications, annual updates, orphan drug designations, and the like. You will review protocol amendments, informed consent form (ICF) and administrative letters for compliance and in alignment with the overall regulatory strategy. 

You will have the oversight for submitting safety reporting to FDA for assigned programs and develop and manage timelines for the preparation of submissions. You will represent the Global Regulatory Affairs function with various internal departments to coordinate activities and assist in the preparation of regulatory submissions. You will interact with other project team members to ensure the timely preparation and receipt of information required for regulatory submissions. You may interact with internal and external partners and vendors to support product development, as needed. You will communicate directly with regulatory authorities (FDA, EMA, MHRA, etc.) and have command of key global guidance documents, regulations, or directives to effectively communicate any impact on development programs. You will also proactively identify potential regulatory issues and recommend innovative and timely solutions. You will ensure regulatory compliance with existing regulatory applications (e.g. IND/CTA maintenance, including submission of Safety Reports, investigator documentation and Annual Reports) throughout the trial's duration for research studies involving human subjects.

 

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. 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 Superpowers

  • You have a bachelor’s degree, preferably in a scientific discipline.
  • You have 5+ years of related pharmaceutical/biotechnology industry, minimum 3 years of Regulatory Affairs experience.
  • You have experience and knowledge in the preparation of global regulatory submissions (e.g., initial IND/IND amendments, CTAs, NDA/BLA/MAA).
  • You possess a knowledge and understanding of applicable global regulations, guidance documents and regulatory pathways.
  • You possess a knowledge of eCTD content/format requirements.
  • You can work both independently with direction and within project teams.
  • You understand relationships are key and have strong interpersonal skills. 
  • You work effectively in a team environment. Teams love working with you and you are someone who takes pride in collaborating and are willing to roll-up your sleeves and get the job done.
  • You thrive in a smaller company environment and love the pace of a true startup.

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.

EQuality Medicines: Equally good or better, innovative medicines

  

EQuitable Medicines: Making innovative medicines affordable

EQual Access: Sustainable, frictionless access for people to cutting-edge medicines

We have a bold mission and are looking for equally bold people who want to join us and help make a difference in the world. If you want to grease the wheel, we are definitely not for you. Want to build the wheel? We might be just what you are looking for.

Apply

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.

The Champion

Are you ready to build a sustainable pipeline of excellent drugs at much lower prices?

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What does EQRx stand for?

  • EQuality Medicines: Equally good or better, innovative medicines
  • EQuitable Medicines: Making innovative medicines affordable
  • EQual Access: Sustainable, frictionless access for people to cutting-edge medicines

We have a bold mission and are looking for equally bold people who want to join us and help make a difference in the world. If you want to grease the wheel we are definitely not for you. Want to build the wheel? We might be just what you are looking for.

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.

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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