Lumanity applies incisive thinking and decisive action to cut through complex situations and deliver transformative outcomes to accelerate and optimize access to medical advances. With deep experience in medical, commercial, and regulatory affairs, Lumanity transforms data and information into real-world insights and evidence that powers successful commercialization and empowers patients, providers, payers, and regulators to take timely and decisive action.

We are a team of scientists, regulatory strategists, and consultants providing a wide range of fully integrated scientific consulting services to industry and counsel. From FDA Advisory Committee meetings to new indications and approvals, we deliver specialized solutions for business hurdles.

We are seeking a Regulatory Writer/Project Manager to handle the regulatory writing related to drugs (including INDs, NDAs, ANDAs, and BLAs) and medical devices (including 510K, RFP, 513G, and PMAs) and manage pharmaceutical projects and coordination of submission timelines.

In this role, you will identify and analyze clinical/regulatory information to support various projects and submissions and develop insightful and meaningful critical analysis of regulatory issues. You will also communicate with clients in regards to project status, interim reports, and final project deliverables as well as develop pharmaceutical development and manufacturing process development reports.

The ideal candidate is inquisitive, ambitious, hardworking and has a strong healthcare regulatory experience along with the following:

• Advanced degree preferred in a life science or related field
• Regulatory Affairs certification (RAC) preferred
• 3 - 5 years relevant experience in regulatory affairs, medical affairs or clinical research related to regulatory submissions
• Proficient and comfortable with scientific/medical data and nomenclature
• Ability to effectively communicate complex scientific and regulatory principles to non-scientists, as well as to scientists and healthcare professionals
• Relevant work experience; preferably in regulatory affairs and/or project management
• Previous experience with regulatory submissions, regulatory body meetings (e.g., FDA Advisory Committees) a plus
• Proficient with Word, Outlook, Excel, and PowerPoint
• Expert skills in internet searching and web browsing
• Eagerness to work independently and in teams in a fast-paced environment
• Excellent ability to interpret scientific charts, tables and figures
• Passion for producing and presenting scientific data in oral presentations or written reports
• Excellent communication skills