We have a responsibility to build upon the incredible progress that has been made in understanding the biology of disease and to develop life-changing medicines that allow for sustainable, equitable access.Alexis Borisy Executive Chairman, Board of Directors
Associate Director/Director, Global Regulatory Affairs
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:
EQRx is a new type of pharmaceutical company committed to developing and delivering innovative medicines for some of the most prevalent disease areas, including cancer and immune-inflammatory conditions. Launched in January 2020, EQRx is leveraging cutting-edge science, technology, and strategic partnerships with stakeholders from across the healthcare system toward the goal of increasing access for patients around the world.
What You’ll Do:
As the Associate Director/Director, Global Regulatory Affairs 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 company.
- You may serve as global regulatory lead or regional lead on assigned programs.
- You will advise on regulatory issues for pipeline products; actively collaborate with management and cross functional colleagues within EQRx (i.e., research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, commercial etc.).
- You will prepare and execute region-specific aspects of regulatory affairs, and ensure integration into global regulatory strategy.
- You will represent EQRx as point contact with regulatory authorities (FDA, EMA, MHRA, etc.), including support for and coordination of regulatory meetings and information package development.
- This role will coordinate submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new INDs/CTAs/MAAs, amendments/supplements, etc.
- 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.
- You will monitor the development of new regulatory requirements or guidance documents and advise program teams of the impact on the business or development programs
- You will provide support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
- You will ensure exemplary behavior, ethics and transparency within the company and with regulatory agencies
The Impact You Will Have
This is not your standard Regulatory Affairs position. We are doing things differently here than how it is normally done, and this role is no exception. This role will help towards our goal of working across the healthcare ecosystem to bring innovative medicines to more patients.
Who You Are
- You have a bachelor’s degree, preferably in a scientific discipline.
- You have 8-10+ 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 fast-growing company.
EQRx seeks to attract and retain the very best talent by offering attractive compensation and benefits packages that include competitive base salaries, performance-based bonus opportunities, long-term equity compensation, flexible spending accounts, company paid insurance coverage (health, dental, vision, life, and disability), flexible paid time off, winter shut-downs, and a 401(k) plan with company match, all subject to the terms and conditions of the applicable plans or programs. EQRx is a virtual first company, although we do encourage our employees to work and collaborate in person when possible.
The US base salary range for this position is $165,000-195,000 however it is not typical for offers to be made at, or near, the top of the range. Actual base salary will be determined based on experience and other job-related factors permitted by law.
Subject to legally required accommodations, candidates should be aware that EQRx currently maintains a policy requiring all employees to be fully vaccinated against COVID-19.
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.
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.
Ready to push beyond boundaries for equitable access for all.
- Problem Solving
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.
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