POSITION SUMMARY:

The Sr. Regulatory Affairs Manager will be responsible for representing the regulatory function on teams working on the development of in vitro diagnostic medical devices for global regulatory submissions. This position will lead, mentor and develop a team within Archer’s primary class of trade.

RESPONSIBILITIES:

• 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.

QUALIFICATIONS

• 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

EDUCATION: