We are seeking a Senior Manager Regulatory for our Companion Diagnostics Development group. This position will be based in our office in Morrisville, NC site.
This position will provide tactical and at times strategic support to the Companion Diagnostics Development and Operational Teams. The incumbent will work to execute the regulatory strategies, contribute to and at times lead FDA pre-submission package development and subsequent meetings, and co-author final product submissions. The incumbent is required to provide guidance to assure that all regulatory submissions are planned, communicated and executed per all appropriate regulatory and business requirements. In addition, this position serves as a subject matter expert regarding various regulations relevant to the diagnostic industry, and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed. Requires the ability to provide solutions based on their own knowledge and industry experience base
Execute on regulatory strategies in support of Companion Diagnostic programs.
Develops clinical regulatory strategies with members of the CDx Regulatory Affairs team, reviewing and providing comments on protocols and development plans.
Participates in the submission of key regulatory filings. May coordinate or lead one or more of the following activities:
Facilitate and prepare U.S. regulatory Pre Submission documents
Facilitate FDA pre submission meetings
Prepare U.S. regulatory submissions (PMA and 510(k))
Support EU representatives in their creation of CE/IVD Technical Files
Communicates with and facilitates interaction with global regulatory agencies
Develops and implement components of regulatory strategies for investigational, and ultimately, commercial drug products
Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic
Communicate application progress to key internal and external stakeholders
Participate in business meetings with potential new external partners
Required: Bachelor's degree in a relevant scientific discipline.
Preferred: Master's, or Ph.D. degree in a scientific discipline.
* 5 years experience supporting regulatory strategies and supporting FDA submissions of in vitro diagnostic (IVD) products with evidence of 510K and/or PMA submissions.
* Demonstrated experience in one or more phases of IVD product development including design control, regulatory package documentation and GMP manufacturing.
* Experience and understanding GxP requirements (GCPs, GLPs, GMPs)
* Experience with drug development, FDA, EMA, and ICH guidelines
* Experience in regulatory environment such as CLIA, CAP, or IVD manufacturing environment.
* Companion diagnostics experience preferred but not required
* Regulatory Affairs Certification (RAC) through Regulatory Affairs Professionals Society (RAPS)
Employer will assist with relocation costs.
Internal Number: 2019-26927
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