Regulatory Affairs Manager

Summary

Join us as the Regulatory Affairs Manager, Gene Therapy CDx to apply high-level expertise and in-depth knowledge of regulatory affairs and marketing authorization process. This position will serve as regulatory liaison/legal manufacturer representative with regulatory agencies and pharma partners for Precision diagnostic products.

Requirements

• 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
• 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

Responsibilities

• Lead the preparation of submissions and other documentation as required for global clearance/approval of Precision’s clinical trial assays and IVD-CDx products
• 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

Preferred Qualifications

• Master’s degree or Ph.D
• CDx experience
• Class III IVD and LDT experience

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation