Sr. Regulatory Affairs Manager (ADX-172-19)
ArcherDX, headquartered in Boulder, CO, is committed to the advancement of personalized medicine by making next-generation sequencing technology more reliable and accessible. We seek like-minded individuals who share our values of curiosity, passion and grit to meet these goals.
Make it happen by joining us in the fight against cancer.
- 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 team of regulatory submission authors.
- 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.
- Two or more years experience managing a regulatory team.
- Experience contributing to core teams with input on key design considerations as reflected in guidance, regulations, or direct feedback from health authorities.
- 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.