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Guardant Health focused on rare-cell diagnostics
 
   Posted: Wednesday, May 08, 2019
 
   
 
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JOB DETAILS
  Company Description

ABOUT OUR COMPANY

We believe conquering cancer is a big data problem. That's why we built the world's leading comprehensive liquid biopsy. This non-invasive tool for accessing & sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries & new products. We're working on some exciting ones, including in early detection, where the impact on patients can be profound. We've raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, & SoftBank.

Job Description

ABOUT THE ROLE

At Guardant Health, we are committed to positively & significantly impacting patient health through technology breakthroughs that pointedly address long-standing unmet needs in oncology. As the leader in the liquid biopsy field Guardant Health has information about the mutational landscapes of over 30,000 patients.

As the Vice President, Regulatory Affairs you will support & provide input into the development of the regulatory strategy. The Vice President has direct responsibility for driving & developing the US & international regulatory plans & filings for both companion diagnostics (CDx) & standalone diagnostics with either the FDA or the EMA. The Vice President. provides expert advice & opinion to teams within the US & international regulatory environment, including guidance in support of the Quality Management System for compliance with the FDA's quality system regulations (cGMPS/QSRs) & ISO13485 Standards.

This position is a management, business & expert role.

Key Responsibilities

  • Provide management & leadership of the Regulatory Affairs organization in the development & implementation of regulatory strategies & processes to gain product approvals worldwide
  • Serve as point of contact & represent the Company before regulatory authorities, including preparation of meeting agendas, materials, & minutes
  • Execute USregulatory project plans in collaboration with oncology management, clinical, CMC & device groups as well as regulatory consultants, & CROs
  • Manage & oversee of all operational aspects of regulatory submissions, including maintaining timelines & developing & coordinating submission content for various regulatory FDA, EMA & PDMA applications, safety, amendments, & IND safety & annual reports
  • Hand maintain awareness of existing & new regulations & guidance for quality, CMC, nonclinical & clinical matters, devices & advise on expectations & requirements for US & OUS compliance
  • Oversee Quality Management Operations
  • Provide counsel, training, & interpretation of FDA & other regulatory agencies to Company personnel
  • Contribute to corporate infrastructure via development of SOPs, work instructions, etc.
  • Develop strategy & assure compliance of devices compliance with FDA regulations & the Medical Device -Directive (MDD) in the EU & other equivalent regulatory requirements at other territories
  • Responsible for the review & approval of promotional, advertising, & labeling items
  • Other duties as assigned
Qualifications

Skills Required

  • Minimum of 10+ years of regulatory experience in US/OUS (EU/Japan) related with pharmaceutical/biotech development & commercialization
  • B.S. / M.S. degree or higher in a life science field is minimum. Ph.D. or equivalent is highly desired. RAC accreditation is desirableIVD & CDxexperience
  • PMA submission experience a plus
  • Extensive knowledge of US FDA/EMA drug/device development process, regulations & guidelines, including GCP.
  • Solid knowledge of Quality Assurance & PAI preparations
  • Good understanding of Quality Assurance & Quality Management Systems to ensure adherence to cGMP & GLP requirement & SOP's
  • Experience in oncology, clinical trials & accelerated approvals
  • Experience in representing the sponsor & interfacing with the FDA, EMA & PDMA
  • Demonstration of successful submissions of INDs, NDAs, BLAs and/or PMAs; experience with drug-device combinations is desirable
  • Extensive knowledge of US FDA/EMA drug/device development process, regulations & guidelines, including GCP. Solid knowledge of Quality Assurance & PAI preparations
  • Good understanding of Quality Assurance & Quality Management Systems to ensure adherence to cGMP & GLP requirement & SOP's
Additional Information

Keywords / #Hashtags

#guardanthealth #gh #biotechjobs #biotechcareers #fda #regulatoryaffairs #regaffairs #oncologyjobs #oncology #ivdjobs #oncologycareers #ivdcareers #pma #ide #biotechnologyjobs #biotechnologycareers #regaffairsjobs #regaffaircareers #vpofregulatoryaffairs

We would like to talk with you about our exciting projects we currently have ongoing. Please see guardanthealth.com/jobs for more information & to apply.

 
 
 
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