Director, Regulatory Affairs (Companion Diagnostics and IVD) - (R1028163) in Research Triangle Park, NC at IQVIA™

Date Posted: 5/30/2018

Job Snapshot

Job Description

Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise.

Description

Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization.  We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise.  The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.
 
PURPOSE:

The Director, Regulatory Affairs will have responsibility for ensuring Companion Diagnostic, IVD and Precision Medicine related activities are performed in accordance with FDA, EU and other international Regulatory standards/guidelines. These activities will cover immediate Q2 Solutions interest but shall also provide advice and guidance for joint efforts within Quest Diagnostics and affiliate organizations. The post holder will play a lead role in shaping, building and maintaining an internal infrastructure and process build towards QSR, CFR 820. The successful candidate should have extensive CDx and IVD experience and be a strong leader with excellent communication and collaboration skills and a proven track record of working with FDA.
 
RESPONSIBILITIES: 
  • Lead all Regulatory communications with FDA and international competent authorities including authoring Pre-IDE, Risk Assessment, IDE and PMA submissions.
  • Lead Regulatory interactions with EU competent authorities to ensure alignment with present CE marking Self Certification and future EU IVD Directives.
  • Working with internal QA, participate in the development, design and implementation of a QSR system at Q2 Solutions.
  • Keep abreast of changing global Regulatory landscapes pertaining to Companion Diagnostics and IVD and make recommendations to the Business to ensure compliance and training.
  • Provide input to early Engagement with Pharma,  BioTech, and IVD manufacturers on appropriate Regulatory strategy to enhance our Business Development Solutions to help secure CDx, IVD and Precision Medicine business for Q2.
  • As required, provide Regulatory Capabilities advice and expertise at Bid Defense and other client facing meetings. Accordingly, some internal and occasional international travel will be required – 5-10%.
  • Contribute to the development of internal and/or external communications including Insight briefs, White paper’s, and capability slide decks.
  • Work with strategic pricing and Operations to develop appropriate pricing/ rate card for Regulatory Services that Q2 offers.
 

Job Requirements

QUALIFICATIONS:
  • BA/BS required; MBA and/or MPH is strongly preferred. A minimum 8–10 years of Regulatory Affairs experience with at least 5+ years of experience in IVD and or CDx development of working with CDRH in a diagnostic company, Pharma industry or Central laboratory. 

SKILLS: 
  • In depth Regulatory background in Companion Diagnostics development and a working knowledge of drug development across all stages of development. 
  • In depth knowledge of clinical testing procedures and applicable laboratory testing regulations.
  • Strong understanding of industry trends as well as Regulatory paths for Companion Diagnostics in vitro diagnostics in US, Europe, Japan and other major markets. 
  • Strong leadership experience with ability to set priorities, direct projects and implement complex strategies and work on cross-functional teams.
  • Excellent written and oral communication skills
  • Excellent client management and problem resolution skills
  • High ethical standards
  • Ability to assess and prioritize multiple tasks, projects and demands
  • Ability to make effective and persuasive presentations on complex topics to clients, senior management and other stakeholders
  • Demonstrate strong leadership skills, can lead by example with a high level of intelligence, and be dedicated to working collaboratively with other functional groups. 
 
 
EEO Minorities/Females/Protected Veterans/Disabled

Job ID: R1028163