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Senior Manager Regulatory (CDX/Clinical Affairs)

Covance 4/9/2019 7:26:15 PM
JOB ID: 26927 Category: Regulatory
Morrisvill, North Carolina



Job Overview

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.


Minimal Requirements:

* 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 developing clinical regulatory strategies and/or clinical plans. Comprehensive understanding of GCPs.

* 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)

Position Type: Full-Time

Location: Morrisvill, NC - North Carolina


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).