Senior Manager, Submissions Management

ABOUT THE FLOCK

The Regulatory flock is all about making a profound impact on people living with rare diseases through teamwork, strategic conviction, operational focus, and individual accountability to the mission of establishing gene therapy as a meaningful option for patients. We are looking for a regulatory submission manager to support marketing and clinical submissions for all therapeutic areas across the portfolio. Come work with a kickass group of birds that are committed to be the change that we want to see in the world….and have some fun together along the way!

HOW YOU’LL FLY

You'll help to bring more patients their bluebird days by:

• Planning, executing, and managing the approval of eCTD sections for regulatory submissions to health authorities
• Partnering closely with regulatory project management to generate submission timelines and content plans to support the development and goals of each program/product
• Working with all major contributing departments, including, but not limited to: Regulatory Science, Regulatory CMC, Medical Writing, Regulatory Operations, Preclinical, Pharmaceutical Sciences, etc. to ensure submission expectations are well understood and timelines are met
• Identifying risks to submission timelines with potential solutions to cross-functional project team and leadership as needed
• Coordinating with publishing colleagues to understand publishing timelines, workload, and any other concerns to ensure planned and required submission dates to health authorities are met
• Serving as the point person for submission activities and sharing best practices within area of specialization.
• Organizing and maintaining team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses / mitigation strategies as it relates to submission management.

WHAT YOU’LL BRING

You’re the bird we’re looking for if you have:

• Bachelor's degree in life-sciences or related field
• 4+ years’ experience working for a company focused on the development of biotech and / or pharmaceutical products
• 2+ years’ submission management experience, including working on submission of at least 1 major marketing application
• Experience developing submission timelines and submission content plans
• Proficient in Project Management software
• Experience using document management / regulatory information management systems
• Familiarity with entire life cycle of drug development and understanding of ICH guidelines and CTD structure