(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, will be responsible for applying expertise in regulatory affairs and marketing authorization processes. The individual will serve as a regulatory liaison with regulatory agencies and pharma partners for Precision diagnostic products, including companion diagnostics (CDx) and laboratory developed tests (LDT).

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 correspondence and meetings with regulatory agencies and Notified Bodies.
• Designing strategic approaches to regulatory approvals and post-market requirements.
• Reviewing and directing the development of analytical and clinical protocols.
• Performing regulatory impact assessment for changes to clinical trial assays and CDx products.
• Supporting Precision’s post-market surveillance program.

Requirements:

• BS Degree in Sciences, or equivalent.
• 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, including US, EU, UK, APAC, and MENA regions.
• Strong written and verbal communication skills in English.
• Ability to prioritize tasks and meet deadlines.
• Strong scientific and analytical skills.
• Strong leadership, team building and interpersonal skills.
• Experience managing staff members and project teams.

Role offers:

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