Director Regulatory Affairs

Company: Champions Oncology Inc.
Location: Rockville
Posted on: June 18, 2022

Job Description:

Job DetailsLevelManagementJob LocationRockville, MD - Rockville, MDRemote TypeFully RemotePosition TypeFull TimeEducation LevelMasters DegreeJob CategoryBiotechJob DetailsAbout us:Champions Oncology is a technology-enabled research organization that leverages an end-to-end range of research and development solutions to improve the productivity of oncology drug development. Using computational and experimental testing platforms, Champions Oncology improves decision making for effective therapeutic development. Our team is passionate and self-motivated working together to accelerate the challenges of oncology drug development and ultimately improve patients' lives around the world.Job Overview: Champions Oncology is advancing therapeutic and biomarker discovery through integrated AI-enabled and experimental workflows. The Manager, Regulatory Affairs will work closely with the therapeutic and biomarker discovery team, as well as with Corporate Development and Strategic Alliances group to help develop the therapeutic and biomarker development regulatory strategy. The successful candidate will have companion diagnostics (CDx) experience and be a strong leader with excellent communication skills and demonstrated ability to work well in a cross-functional, fast-paced environment. Duties and responsibilities:Develops CDx regulatory strategies for biomarker partnershipsParticipates to the evaluation and assessment of external Diagnostic partnersInteracts directly with the FDA and other regulatory bodies, as applicableProvides interpretative guidance on regulatory requirements on projectsProvides regulatory expertise internally and externallyCollaborates with external partners to ensure successful submission for companion diagnostic productsProvides oversight and project management towards regulatory activities performed by 3rd party CDx partners.Demonstrates expertise and knowledge of submission and technology-related global health authority guidelines.Leads the overall regulatory affairs, including but not limited to intelligence, submission and strategy scope including partner relations.Keeps abreast of current industry trends and global regulatory landscapes pertaining to CDxQualifications, Skills and Abilities: Advanced scientific degree (Masters and above)Minimum of 5 years pharmaceutical or diagnostic experienceExtensive experience in regulatory affairs and companion diagnostic regulatory processesExcellent written and verbal communication skillsDemonstrated ability to work in a fast paced and cross-functional environmentExperience with oncology CDx is a plusExtensive knowledge of global regulatory requirements and guidelinesProven leadership in defining regulatory strategy for CDxExperience with both Laboratory Developed Tests and FDA landscapesThis job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary. Champions Oncology is an Equal Opportunity/ Affirmative Action Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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