Position Summary:

The Regulatory Affairs Manager, Gene Therapy CDx is located in the United States and will be responsible for applying high-level expertise and in-depth knowledge of the regulatory affairs and marketing authorization process.  This position will also serve as regulatory liaison/legal manufacturer representative with regulatory agencies and pharma partners for Precision diagnostic products (e.g., companion diagnostics [CDx] and laboratory developed tests [LDT]).

Essential functions of the job include but are not limited to:

• Lead the preparation of submissions and other documentation as required for global clearance/approval of Precision’s clinical trial assays and IVD-CDx products, including the preparation of regulatory submissions, meeting packages, and negotiations with regulatory officials as required
• Serve as a regulatory lead on Precision CDx program development project teams, contributing toward DHF documentation, project plans and participating in meetings with pharma partners
• Represent Precision in correspondence and meetings with regulatory agencies and Notified Bodies
• Design strategic approaches to regulatory approvals, clearances, and post-market requirements to support co-development programs and reflect optimal business solutions for pharma partners
• Review and direct the development of analytical and clinical protocols, technical reports, and other company documents for use in regulatory submissions and in response to queries from regulatory agencies globally
• Review and edit regulatory communication, submission, timeline, and approval requirement documents for assigned programs and other initiatives
• Stay abreast of latest regulatory developments on a global scale and communicate to the project teams for impact and possible implementation within Precision’s CDx programs
• Perform regulatory impact assessment for any changes to clinical trial assays and CDx products for reporting to regulatory agencies
• Support Precision’s post-market surveillance program

Qualifications:

Minimum Required:

• BS Degree in Sciences, or equivalent in a Scientific, or similar discipline
• Minimum of 5+ years of regulatory experience working in a medical device industry, specifically in-vitro diagnostics, preferably with gene therapy and/or CDx
• Demonstrated knowledge and understanding of global IVD regulations, including but not limited to US, EU, UK, APAC, and MENA regions.

Other Required:

• Strong written and verbal communication skills; highly proficient in spoken and written English is a requirement, proficiency in other languages is a plus
• Ability to prioritize tasks, deadline-oriented, and good organizational skills.
• Ability to think outside of the box and solve difficult problems with effective solutions
• Committed attention to detail
• Strong scientific and analytical skills
• Strong leadership, team building and interpersonal skills
• Direct experience working with small and large companies to design global regulatory and commercialization strategies
• Experience managing staff members and project teams

Preferred:

• Master’s degree or Ph.D.
• CDx experience
• Class III IVD and LDT experience
• FDA: PMA, IDE, and Q-Submissions
• EU IVDR experience: Annex XIV, ethics committee submissions, and CE Mark