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:
The Regulatory Intern will be responsible for supporting regulatory and submissions teams through the operational management of product and Health Authority information as well as applications in various systems. He/she will support EQRx’ efforts to obtain/maintain worldwide approvals to market our products. The Regulatory Strategy Intern will be a member of the Global Regulatory Team (GRT) and teams responsible for evaluation of product concepts.
Job Responsibilities and Requirements:
• Manage regulatory document, data and information within systems
• Participate in the electronic review and quality verification of regulatory submissions
• Support development and management of submission plans and timelines to ensure submissions are timely and objectives are met
• Support operational management of documents and information in regulatory systems
• Document regulatory contacts and correspondence with Health Authorities
• Support preparation of IND, NDA, and BLA submissions which may include original marketing applications, clinical trial applications, amendments, supplements, variations, responses to Agency questions and requests, meeting requests, briefing packages, annual reports, periodic safety reports, etc. Help manage the internal review and submission of these items
• Support management of consistency, completeness, accuracy, and adherence to regulations and applicable guidelines for regulatory submissions
• Support the management of regulatory intelligence information which may include the review of recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
• Other responsibilities as assigned
The Impact You Will Have:
Regulatory professionals are the gatekeepers of information flowing between the company and the Health Authorities. You will have the opportunity to contribute to the detailed work that is required to move information through the gate. In this role you will have an opportunity to work with or across regulatory functions, learn about Health Authority interactions and experience the work of cross functional submission teams in a matrix environment. This will provide insight into the many different roles that are required to support bringing medicines to patients.
Your Professional Superpowers:
At this point, you may or may not have determined your professional superpowers however this opportunity may allow you to do so.
Minimum Requirements
:
• Enrolled in a Bachelor’s or Masters or advanced degree program in a scientific discipline, with 0-1 years of responsible experience in the pharmaceutical industry
• Excellent verbal and written communication skills
• Ability to work with limited supervision, to set priorities to meet timelines
• Exceptional interpersonal skills with the ability to work individually and within a multi-disciplinary team
• Some travel will be required
• 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’re a team player who is willing to roll-up your sleeves and get the job done.