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Director, Regulatory Affairs

Company: EQRx, Inc.
Location: Cambridge
Posted on: February 25, 2021

Job Description:

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 The Director, Regulatory Affairs will implement the overall Regulatory strategy for the business and lead the clinical team in the execution of regulatory strategies for the portfolio of projects and products. You will be responsible for the coordination, preparation and review of regulatory submissions (US) for small molecules in support of clinical trials. You will also be responsible for the preparation and assembly of documentation required for pre-IND meetings (PIND), Investigational New Drug Applications (IND), Investigational Medicinal Product Dossiers (IMPD) and Clinical Trial Applications (CTA) for initial application and annual updates. You will review protocol amendments, informed consent form (ICF) and administrative letters for compliance with FDA. You will be responsible for supporting cross-functional activities pertaining to regulatory meetings, including the development of briefing documents and conduct of meeting rehearsals. You will ensure regulatory compliance with existing regulatory applications (e.g. IND maintenance, including submission of Safety Reports, investigator documentation and Annual Reports) throughout the trial's duration for research studies involving human subjects. You will submit SAE reports to FDA and develop and manage timelines for the preparation of submissions. You will represent Regulatory Affairs 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. Interacts with internal and external partners as necessary to support product development. You will communicate with regulatory authorities (FDA, EMA, HC, etc.) and be knowledgeable of key global guidance documents, regulations, or directives and effectively communicate any impact on development programs. You will maintain the clinicaltrials.gov database for development products and maintain regulatory documents on secure shared database. You will also proactively identify potential regulatory issues and recommends solutions. 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.
  • You have a BA/BS degree, preferably in a scientific discipline.
  • You have a minimum 10 years of experience in the pharmaceutical/biotechnology industry with at least 5 years of regulatory affairs experience and minimum of 3 years of GCP auditing 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 generate development options and present risk/benefit analyses in order to collaborate with and influence cross functional teams.
  • You can work both independently with direction and within project teams.
  • You can participate and work effectively on multiple cross-functional teams.
  • You play well in the sandbox. 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. 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 , Director, Regulatory Affairs, Executive , Cambridge, Massachusetts

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