San Francisco, CA, USA
about 1 year ago
My client, a market- lead in Biotechnology and Diagnostics, is looking for a Senior Director of Regulatory for Clinical Diagnostics who will be part of an innovative organization making a real impact on improving the quality of life globally. The Senior Director of Regulatory for Clinical Diagnostics will be responsible for working collaboratively towards defining appropriate regulatory pathways which align with the company's corporate objectives. The successful candidate will lead timely and effective regulatory plans for the company's diagnostic products, while advising product development, and ensuring regulatory compliance.
The Key Respeonsibilities include:
- Working collaboratively and cross-functionally to ensure regulatory objectives are aligned with the company's corporate goals and objectives.
- Providing management and leadership in the development and implementation of regulatory strategies and processes to inform Diagnostics commercialization plan approvals.
- Leading and mentoring Regulatory Affairs direct reports, deligating appropriate levels of accountability for decision making and clearly communicating requirements and plans.
- Providing counsel, training and interpretation of FDA and regulatory requirements.
- Overseeing preparation and filing of all Diagnostics regulatory documents with the FDA and international regulatory agencies, within applicable regulations and guidelines.
- Providing regulatory oversight and guidance for compliant product promotion.
-Developing and maintaining external relationships with relevant opinion leaders and regulatory officials.
- Working cross-functionally with collaborators to support pharma partner regulatory requirements.
- Directing the development of systems, practices, and processes to ensure effective ongoing review of product design or other operational and manufacturing changes.
- Providing leadership, direction and oversight to manage deviation events that may impact compliance status or create business risk.
The Key Qualifications Include:
- BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree strongly preferred.
- 10+ years of progressive management experience in global regulatory affairs in a diagnostic, medical device or life sciences technology driven company.
- Experience with product submissions in multiple therapeutic areas (hematology, oncology, immunology) and NGS technology highly preferred.
- Experience in strategic planning and collaboration with executives, key operational groups and external partners.
- Expertise with all phases of the product development lifecycle, including feasibility, design, development, transfer, verification and validation activities necessary for research and diagnostic product commercialization.
- Extensive experience in ISO, CLIA, CAP, CLEP, GxP and other Regulatory compliance requirements.
- Proven hands on experience in submission and approval of global regulatory filings and reporting for US (510(k)) and other key countries/regions, including CE marks.
- History of successful direct interactions and negotiations with regulatory agencies.
Key Skills and Knowledge Include:
- High level of personal and professional integrity and trustworthiness with strong work ethic.
- Excellent communication skills (written and verbal) and presentation skills.
- Solid knowledge of and experience in strategic planning, risk management, diagnostic product development and operations.
- Extensive ability to analyze complex situations and propose practical solutions.
- Ability to develop and manage a high-performance team focused on accountability and exceeding expectations.
- Effective interpersonal skills including ability to lead, influence, create and work within cross-functional team environments.
- Proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done.