Regulatory Operations Manager

US-PA-Philadelphia
4 days ago
Job ID
2017-28108
Category
Management
Position Type
Perm
# of Openings
1

Overview

 Manager - Regulatory Affairs

 

Responsibilities

Responsibilities:

  • Lead Regulatory Affairs transformation projects for Life Sciences clients
  • Provide oversight of client and Company’s work teams throughout the project lifecycle and help ensure timely execution of project deliverables
  • Execute process transformation, measurable improved operational performance, and organizational restructuring
  • Lead analysis on regulatory-related data, processes, business requirements, operating models, etc.
  • Communicate business process improvement opportunities to Regulatory Affairs clients
  • Assist with proposal development and other new business development activitie.

 

Qualifications

Qualifications:

Five years of work experience related to the Regulatory Affairs function within the pharmaceutical and/or medical device industry; one year of experience with implementation or optimization of at least one of the software packages related to: Document Management, Publishing, or Registration Management; prior professional services or consulting experience preferred
Bachelor’s degree in an appropriate field from an accredited college/university; Master’s degree from an accredited college/university preferred
Strong understanding of Regulatory Affairs related data and documents
Experience with Regulatory Information Management (RIM); knowledge of ISO IDMP and/or UDI / EUMDR preferred
Experience in project management and oversight, including supervising staff level engagement teams in the field, providing input into engagement decisions /contract management, and operational restructuring
Travel may be up to 80-100%

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