(Associate) Director Regulatory Affairs, Gene Therapy

Job Description

Precision Medicine Group is seeking a Regulatory Affairs (Associate) Director, Gene Therapy CDx. This role, based remotely in the United States, requires expertise in regulatory affairs and marketing authorization processes. The individual will act as a regulatory liaison between Precision and regulatory agencies, as well as pharma partners, focusing on precision diagnostic products like companion diagnostics (CDx) and laboratory developed tests (LDT).

The role involves:

• Leading the preparation of submissions for global clearance/approval of clinical trial assays and IVD-CDx products.
• Serving as a regulatory lead on Precision CDx program development project teams.
• Representing Precision in communications with regulatory agencies and Notified Bodies.
• Designing strategic approaches to regulatory approvals and post-market requirements.
• Reviewing analytical and clinical protocols and technical reports.
• Performing regulatory impact assessments for changes to clinical trial assays and CDx products.
• Supporting Precision’s post-market surveillance program.

Requirements include:

• BS Degree in Sciences or equivalent.
• Minimum of 12+ years of regulatory experience in the medical device industry, specifically in-vitro diagnostics, preferably with gene therapy and/or CDx.
• Knowledge of global IVD regulations (US, EU, UK, APAC, MENA).
• Strong written and verbal communication skills in English.
• Ability to prioritize tasks and strong organizational skills.
• Strong scientific, analytical, leadership, and interpersonal skills.
• Experience working with small and large companies on regulatory and commercialization strategies.
• Experience managing staff members and project teams.

The role offers:

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