Associate Director of Global Regulatory Operations

Company: EQRx, Inc.
Location: Cambridge
Posted on: April 5, 2021

Job Description:

Associate Director of Global Regulatory Operations Regulatory Cambridge, Massachusetts, United, States Full-Time As a society, we've recognized an increasing need to rethink the value of best-in-class medicines and make a shift to consider both the science and the cost, with the goal of expanding access to high-quality medicines. 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 As Associate Director Regulatory Operations, you will play a key role in our highly dynamic organization. You will oversee the end-to-end submission execution activities including, planning/scheduling, publishing, QC and dispatch/transmit our regulatory submissions to health authorities per guidance. You will participate in the building of a Best in Class Regulatory Operations team. You will work closely with your Regulatory and cross-functional colleagues and provide vendor management oversight to ensure compliance to our submission standards. You will serve as the Business Owner for the publishing system, which includes active participation in publishing system maintenance and backup activities by partnering with the Informatics team for system validation and establishing system specific business requirements. This role will be responsible for the development of country specific submission requirements manuals and maintenance based on industry and country requirement changes. To support these efforts, you will need to monitor changes in regulations and guidelines for submission publishing impact, participate in industry engagements, disseminate relevant changes in regulations and guidance to affected parties and design and direct implementation of training as required to support changes. You will serve as an SME (subject matter expert) to submission filing teams to ensure filing excellence. You will develop global strategic plans to support current and future health authorities' submission requirements to apply consistency for all EQRx submission publishing standards and processes. You will also assist in developing, implementing, and communicating the Global Regulatory Operations vision, metrics, budget activities, core capabilities, process improvements and value while championing a strong Submission Excellence Culture. 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 Superpowers -- You have a bachelor's or master's degree. -- You have significant pharmaceutical/biotechnology industry experience, with a minimum of 5+ years within Regulatory Operations. -- You have a thorough understanding of process and technology solutions. -- You have 5+ years of hands-on experience with a variety of regulatory e/CTD submission dossiers from clinical development through commercialization (IND, IMPD, CTA, NDA, NDS, BLA, MAA), briefing documents, agency queries and responses, and other submission dossier types. -- You have knowledge and experience with electronic content/document management systems, preferably Vault RIM, eCTD publishing tools, and publishing systems. -- You are knowledgeable of pharmaceutical regulations including, ICH guidance, GxP, and good -- You possess strong communication, organizational and presentation skills. -- You can participate and work effectively on multiple cross-functional teams. -- You understand relationships are key and have strong interpersonal skills. -- 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'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?-- EQ uality Medicines: Equally good or better, innovative medicines EQ uitable Medicines: Making innovative medicines affordable EQ ual 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. 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 Dreamer Are you ready to think differently and embrace the journey?

• 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. Find Your Professional
      SuperpowerWhat's yours? Find the right job for your skills. Stay in the Loop Get Job Alerts Follow on social. Stay connected on Glassdoor, Instagram, Twitter & LinkedIn!
      • 50 Hampshire Street
        Cambridge, MA 02139
        (617) 315-2255 Two-hour street parking is available. There are also several parking garages in the surrounding area.

Keywords: EQRx, Inc., Cambridge , Associate Director of Global Regulatory Operations, Executive , Cambridge, Massachusetts