Director Regulatory Affairs
Company: Champions Oncology Inc.
Location: Rockville
Posted on: June 18, 2022
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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.
Keywords: Champions Oncology Inc., Rockville , Director Regulatory Affairs, Executive , Rockville, Maryland
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