Head of Quality & Regulatory Affairs

We are seeking a highly motivated and skilled Head of Quality and Regulatory Affairs to lead our FDA submissions for our novel precision medicine testing products and provide oversite and management of the company’s quality assurance program.  The ideal candidate will have extensive experience in submitting IVD/510K /DeNovo products through the regulatory process and knowledge of FDA design control procedures. The ideal candidate will have brought a diagnostic test/product through validation into regulatory submission.

RESPONSIBILITIES

· Develop regulatory strategic plans for project teams to gain earliest regulatory approvals in the US, and possibly other countries. Works with project teams to resolve complex project issues. Supports team interactions and alignment with partners. Utilizes expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Represent PreludeDx before regulatory authorities.

· Assists in the design and development plans for Clinical Studies required for Regulatory Approvals.

· Responsible for filing of regulatory submissions. Sets strategy for submissions of product registration documents to health authorities. Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions. Represents Regulatory Affairs in product life cycle development teams by reviewing, approving, and completing requirements.

· Responsible for keeping management team informed of regulatory status of programs and significant regulatory issues. Able to present and implement project related regulatory strategy with all Project Teams. Assures compliance with project team timelines and milestones.

· Collaborates with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions.

· Effectively plans, organizes, and conducts (or supervises) formal meetings with regulatory agencies. Interacts with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.

· Provides counsel, training, and interpretation of FDA’s and other regulatory authorities’ feedback, policies and guidelines to PreludeDx and assists as a liaison between PreludeDx and regulatory authorities.

· Lead the company’s overall Quality Assurance Program to ensure compliance with government and regulatory bodies including CLIA, CAP, NYSDH and local.

EXPERIENCE & QUALIFICATIONS

· Bachelor’s Degree in Life Sciences discipline or equivalent, with advanced degree (MS/PhD/PharmD) preferred.

· Minimum of ten (10) years of relevant clinical regulatory and QA leadership experience in the biotechnology industry. Oncology and diagnostics experience a plus.

· Experience in regulatory environments such as CLIA, CAP, or IVD manufacturing environment.

· Proven track record of success in supporting successful progressing programs including Lab Developed Tests (LDT) and/or 510K early and late-stage development plans to completion with FDA.

· Demonstrated experience in the phases of IVD product development including design control, regulatory package documentation and GMP manufacturing.

· Excellent track record for oncology or similar product approvals in the US and EU preferred. Proven success in communicating and negotiating with FDA and global health authorities.

· Proven ability to develop and manage a high-performance regulatory team focused on accountability and meeting and exceeding expectations. Also experienced in building the regulatory infrastructure needed in a maturing small biotechnology company.

· Strategic thinking, leadership skills, assertiveness, strong technical background, and project management skills as evidenced by past performance on product development project teams.

· Excellent interpersonal & communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations.

· Experience developing companion diagnostic regulatory strategy a plus.

The annual base salary range for this position is $160,000 - $250,000. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. Base salary is only one element of employee compensation at PreludeDx. Total compensation can include bonuses and equity awards.