Senior Director, Clinical Regulatory Affairs

🔥 14 hours ago

⛰️ Colorado, Washington – Remote

⛰️ Colorado – Remote ☕ Washington – Remote

💵 $249.9k - $362.3k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Umoja Biopharma

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $210M Series B on 2021-06

Healthcare • Consulting • Manufacturing

Umoja Biopharma is a pioneering biopharmaceutical company focused on developing innovative in vivo CAR T cell therapies for cancer treatment. Their flagship technology, the VivoVec platform, enables the generation of CAR T cells directly within a patient's body, significantly streamlining the process compared to traditional ex vivo methods. Umoja Biopharma is dedicated to enhancing patient care by making cancer treatments more accessible and effective, backed by their own in-house manufacturing capabilities that ensure quality and reliability in their therapeutic production.

📋 Description

• Provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs • Develop and execute global regulatory strategies supporting indication selection, trial design, endpoints, and program advancement • Develop registration strategies and plans, including TPP development and assessment, to achieve regulatory approvals and desired product labeling • Lead global regulatory filings, including IND, CTA, BLA, and MAA submissions • Serve as the primary point of contact with global regulatory agencies • Communicate regulatory strategy, risks, mitigations, and plans to Regulatory Affairs, program teams, senior management, and external stakeholders • Identify, communicate, and propose resolutions to routine and complex issues • Provide regulatory advice and guidance to project teams based on scientific data, regulatory guidance, and precedent • Collaborate with translational medicine, preclinical, clinical, CMC Regulatory, and technical teams • Monitor emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas • Conduct regulatory research and interpret regulatory authority feedback, policies, guidelines, and directives • Work with external program partners to deliver contractual obligations and corporate priorities • Provide organizational support and mentoring as the company grows its product development pipeline

🎯 Requirements

• Senior Director level: PhD/MS/BS in a relevant scientific field required, with a minimum of 12/15/15+ years, respectively, of relevant regulatory affairs experience • Executive Director level: PhD/MS/BS in a relevant scientific field required, with a minimum of 15/18/18+ years, respectively, of relevant regulatory affairs experience • Experience in Oncology, Hematology, or related specialty strongly preferred • Successful track record of regulatory submissions and approvals • Demonstrated expertise in cell & gene therapy • Experience with CAR-T or T-cell engaging modalities preferred • Experience in in vivo gene delivery is a plus • Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies • Proven ability to interact with regulatory authorities • Ability to travel approximately 20% for team meetings and/or regulatory interactions; some international travel possible • Ability to sit for prolonged periods of time

🏖️ Benefits

• Competitive Medical plans • Dental plans • Vision plans • 401k plan through Fidelity • 100% match up to the first 4% deferral • Generous Paid Time Off policy • Employee commuter benefits • Cell phone stipend