LOCATION: SAN MATEO, CA
Too frequently, physicians exhaust all available treatment options for cancer patients. However, every cancer tumor contains unique genomic changes that can be targeted to attack the tumor. Our Client had devel-oped sequencing which unlocks the genomic information physicians need to optimize treatment providing DNA-based cancer testing technology.
The Regulatory Affairs professional will be responsible for developing regulatory strategies to enable ongoing Oncology clinical trials, managing regulatory submissions, and communication with health authorities. They will be responsible for supervising external resources involved in submis-sions and facilitating interactions with regulators for clinical trial initiation and closure. Interactions are with US, European and other international regulatory authorities.
They will participate in project teams providing current regulatory guid-ance and direction to multidisciplinary product development partners composed of internal, external and consultant experts in the field. He/she will maintain regulatory research databases on relevant fields in the assigned product area(s) and initiate technical and professional meetings to bring together key opinion leaders on regulatory related top-ics.
• Develop and communicate regulatory strategies for new products, including regulatory consultations, product characterization and safety assessments.
• Supervise contracted resources to support regulatory submissions in alignment with policies and procedures.
• Manage department budget and coordinate all consultant and ex-ternal resource contracts.
• Communicate and network with scientific and regulatory colleagues to obtain and share relevant information within the organization.
• Lead the preparation of submission packages for regulatory agen-cies across multiple international regions in compliance with estab-lished external standards.
• Project manage assigned product submissions to ensure success of development projects at all stages in the regulatory process.
• Organize meetings with regulatory agency staff and key opinion leaders in the regulatory field
• Conduct literature searches and review literature for scientific and regulatory impact.
• Domestic and international travel.
Experience and Skills:
Master’s degree preferred in a scientific or healthcare discipline.
Five or more years of regulatory experience and 3 or more years biolog-ical experience relating to oncology product development – e.g. manufacturing, laboratory management, preclinical safety, research. OR Post Doc regulatory experience.
Experience with USFDA – both CBER and CDER preferred.
Excellent written and oral communication skills and a good working knowledge of Microsoft Office applications (WORD, PowerPoint, EXCEL, Project)
Experience in the preparation of regulatory dossiers and/or face-to-face meetings with regulators in the US and Europe.
Experience in working with regulatory consultants and contract research organizations.
Experience managing clinical programs, CROs, budgets, and timelines required
Excellent oral, written, and medical communication skills required
Join this exciting team and be a part of developing something truly meaningful!
Our client works hard, and has fun doing it. More importantly, they have an enormous amount of respect for one another, and recognize that the key to success is the joy and passion of its people. Every aspect of their culture fosters this belief.
We want people who don’t want to simply work but who are motivated, curious and committed to this goal of improving cancer patient’s survival rates.
RELOCATION ASSISTANCE, SOLID SALARY, EQUITY, GREAT BENEFITS
For consideration and additional information about this exciting opportunity please submit your resume/CV to email@example.com