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REGENXBIO · 19 hours ago

Director, Regulatory Affairs

Rockville, MD

Full-time

Onsite

Director/Executive

10+ years exp

REGENXBIO is an exceptional place to work, focusing on innovative gene therapy products. As the Director of Regulatory Affairs, you will develop and execute global regulatory strategies, ensuring compliance with U.S. and international requirements while engaging with stakeholders and contributing to industry workgroups.

BiopharmaBiotechnologyGeneticsTherapeutics

Responsibilities

Develop regulatory strategies for new products and prepare and submit all necessary applications, reports, and correspondence to regulatory agencies

Monitor global and local regulatory environments affecting approval of advanced therapies and products of interest to REGENXBIO

Anticipate the impact of the changing domestic and international regulatory environment on development plans, registrational strategies, and post-marketing responsibilities

Build internal dashboard of regulatory science and policy resources including guidance documents, relevant regulatory decisions, and other content

Partner with the Regulatory Function to ensure regulatory strategy and execution for pipeline products in early-stage development are well aligned

Travel up to 20% of the time is required

Qualification

Regulatory strategy developmentGene therapy experienceFDA/EMA submission preparationGlobal regulatory quality requirementsStakeholder communicationResilienceLeadership skillsProblem-solving abilityFlexibilityDecision-making capability

Required

Doctorate level or masters required (MD or PhD, MS in Science/Biotechnology/Regulatory or equivalent) with at least 10 years of relevant experience required

Demonstrated ability to lead and motivate people

Ability to proactively predict issues and solve problems

Flexible, resilient, resourceful, entrepreneurial, innovative, and conducts all activities in a highly ethical manner

Experience with global regulatory quality requirements

Proactive approaches to problem-solving with strong decision-making capability

Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and health authorities

Travel up to 20% of the time is required