Regulatory Affairs Manager (ADX-87-20) at ArcherDX
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- Represent regulatory on the program core team, which handles escalation from project teams on issues of study design, timeline changes and resource constraints.
- Develop, mentor, and coach a productive and efficient regulatory team.
- Demonstrate accountability for all program goals, timelines, and compliance decisions to functional management.
- With your team’s support, develop a cohesive and detailed regulatory strategy for meeting Archer’s goal to commercialize an industry leading companion diagnostic IVD platform.
- Provide input on IVD development and clinical trial questions to promote compliance and fidelity to health authority guidance, regulations and feedback.
- Request and drive quality feedback from health authorities in the form of pre-submission meetings.
- Promote consistency in regulatory department feedback in a cross-functional environment through high-quality training and team communication.
- Speak for the Archer regulatory team to external partners, such as pharmaceutical co-development partners.
- Support the Quality group with input the quality management system and strong ownership of regulatory processes.
- Perform other duties as assigned by supervisor, including case-by-case general compliance matters.
- Five or more years experience in regulatory affairs, including primary submission ownership.
- One or more years experience managing a regulatory team.
- High degree of proficiency with MS Office and Adobe PDF creation
- Familiarity medical device and/or IVD design control processes
- Experience with good manufacturing practice and good document practice.
- Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.
- Fine research skills with a knack for sketching out solutions to novel issues.
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
- Ability to work independently, and report progress efficiently.
- Ability to multitask and work within a fast-paced dynamic team environment
- Minimum B.S./B.A, preferably in a technical field.