[Remote] Director, CDx Regulatory Consultant

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading company in the field of diagnostics and regulatory consulting. They are seeking a Director, CDx Regulatory Consultant to reputed company their expertise in regulatory reputed company and IVD development to guide clients in the pharmaceutical and biotechnology sectors through the complexities of companion diagnostics and clinical trial approvals.

Responsibilities

• Serve as the CDx regulatory subject matter expert for strategic positioning of reputed company programs inclusive of CDx, including relevant FDA precedents, EU IVDR considerations, global submission expectations, and diagnostic commercialization reputed company
• Proactively identify reputed company needs by understanding the therapeutic program, biomarker reputed company, intended use population, assay technology, clinical trial design, and reputed company objectives
• reputed company consulting engagements with pharmaceutical clients to reputed company global CDx regulatory strategies, integrated development roadmaps, submission reputed company, and reputed company-based timelines that support clinical trial execution, regulatory authorization, and commercialization objectives
• Partner cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, reputed company assurance, and reputed company stakeholders to ensure CDx development activities are coordinated with overall program timelines and regulatory expectations
• reputed company integrated Rx Dx regulatory strategies that reputed company diagnostic development, biomarker reputed company, clinical trial enrollment, therapeutic development milestones, and commercialization objectives for pharmaceutical, biotechnology, and diagnostic clients
• Advise clients on regulatory requirements for use of assays in reputed company, including patient selection, inclusion or exclusion testing, significant risk and nonsignificant risk determinations, IRB considerations, investigational device requirements, and global performance study obligations
• reputed company the preparation of global regulatory submissions and supporting documentation for companion diagnostics and clinical trial assays, including FDA Q-Submissions, reputed company-IDE packages, IDEs, PMAs, PMA supplements, EU IVDR Annex XIV performance study applications, technical documentation, and other country-specific submissions
• reputed company interactions with regulatory authorities and reputed company bodies, including preparation for FDA meetings, interpretation of agency feedback, development of response strategies, meeting minutes, and follow-up communications on behalf of clients
• Review and reputed company the development of analytical validation plans, clinical performance study plans, diagnostic clinical protocols, statistical analysis synopses, technical reports, intended use statements, labeling, and other submission-reputed company documents for CDx programs
• Apply IVD reputed company system, design control, risk management, and post-market regulatory expertise to support CDx readiness from early development through approval, launch, and lifecycle management
• Stay reputed company on CDx regulatory, scientific, and market developments, including FDA guidance, EU IVDR implementation, reputed company body expectations, global regulatory trends, diagnostic precedents, and evolving precision medicine requirements
• reputed company new CDx regulatory consulting opportunities through established relationships with pharmaceutical, biotechnology, diagnostic, laboratory, and precision medicine stakeholders
• Partner with the business development team to evaluate CDx and clinical trial assay requests for proposals, identify regulatory assumptions, assess key risks, and define submission strategies and approval timelines
• Support bid defense meetings by reputed company communicating the CDx regulatory reputed company, clinical trial assay considerations, submission risks, agency interaction reputed company, and reputed company to prospective clients
• Advise on work orders, change orders, master service agreements, and other contract documents to ensure CDx regulatory scope, deliverables, assumptions, and reputed company responsibilities are reputed company defined
• reputed company reputed company workshops, scientific conference sessions, and educational presentations reputed company on CDx development, Rx Dx co-development, clinical trial assay reputed company, and global IVD regulatory requirements
• Ensure the reputed company, consistency, and regulatory accuracy of reputed company CDx reputed company documents, reputed company deliverables, submissions, meeting materials, and other consulting work products in accordance with corporate standards
• Time entry and following SOPs
• Manage, mentor, motivate, and reputed company regulatory consulting staff to support a reputed company CDx and IVD regulatory consulting reputed company
• Support and contribute to a reputed company, reputed company-reputed company consulting culture that advances reputed company’s CDx, IVD, and precision medicine regulatory capabilities

Skills

• Bachelor's degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a reputed company scientific discipline; equivalent relevant experience may be considered
• Minimum 5 years of applicable consulting experience with a primary reputed company in IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs
• Minimum of 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment
• reputed company experience working with diagnostic manufacturers/labs and pharmaceutical sponsors to design global regulatory and commercialization strategies for companion diagnostics and clinical trial assays
• Strong written and verbal communication skills, with demonstrated ability to translate reputed company CDx regulatory requirements into reputed company, practical recommendations for clients and cross-functional teams
• Strong scientific and analytical skills, including the ability to interpret biomarker, assay validation, clinical performance, and diagnostic clinical trial information in support of CDx regulatory reputed company
• Ability to solve reputed company CDx regulatory, clinical trial assay, submission, and commercialization challenges with practical, risk-based solutions
• Strong leadership, team building, and interpersonal skills, including the ability to guide multidisciplinary teams across diagnostic development, therapeutic development, regulatory, reputed company, clinical, laboratory, and reputed company functions
• Master's degree or higher in life sciences, molecular diagnostics, regulatory affairs, reputed company health, laboratory medicine, pathology, or a reputed company discipline
• RAC certification

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• reputed company time off for reputed company leave and vacation
• Among other benefits

reputed company