Director Global Regulatory Affairs

Job Details

Location

Location Flexible

Expiration Date

Wednesday, May 16, 2018

Interest Area

Law, Policy, Project Management

Position Type

Full-Time

Position Level

Mid-career

Minimum Degree Requirements

College Degree

Company Name

PRA Health Sciences

Job Posting URL

Responsibilities

  • Provides line management to direct reports, including professional development, performance appraisals and employee counseling/mentoring.  
  • Oversees line management of indirect reports ensuring their professional and career development needs are being met by their FM.  Coach the FM as required.
  • Oversee performance of direct and indirect reports and anticipate performance issues, implementing recovery strategies as soon as possible and if not successful, lead or support the Performance Improvement Plan or disciplinary procedures as appropriate in conjunction with HR. 
  • Manages and coordinates resources including the review of workloads of direct reports and the wider team as required. 
  • Offers senior level consultancy for internal and/or external clients in area of expertise.  Identifies and responds appropriately to issues and problems, providing adequate and/or innovative solutions.
  • Acts as Global Regulatory Affairs Program Oversight on assigned projects.  Forms a collaborative relationship with internal and external clients in order that issues are escalated and dealt with appropriately.  Applies learnings across the portfolio.  
  • Advises, consults and makes final recommendations in the area of expertise both internally and to clients. 
  • Keeps abreast of current data, trends, knowledge, and advances in area of expertise, including Regulatory knowledge, trends, and developments as they relate to the area of expertise. 
  • Executes independent judgement
  • Provides long-range product planning. 
  • May serve as Project Manager or technical lead on a regulatory project.  May serve as technical lead for a regulatory function.
  • Works independently, with minimal direction from management.  Identifies direct report training needs and ensures that all training needs are met.  May provide scientific and technical training of local personnel or other staff, as appropriate.
  • Interacts with Regulatory Agencies as required.  
  •  Lead and support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs, including representing GRA at internal and external BD meetings.
  • Presents or Represents of PRA at professional meetings. Consults for internal and/or external clients in area of expertise. Identifies and responds appropriately to issues and problems, providing adequate and/or innovative solutions. 
  • Advises, consults and makes final recommendations in the area of expertise both internally and to clients. 
  • Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up to date; communicate new information or changes to the Regulatory Intelligence Consultant team.  
  • Create, establish and maintain policies and process documents, collaborating with stakeholders as appropriate. 
  • Lead assigned GRA work streams and lead or act as GRA representative on global process improvement work streams 
  • Training development and delivery