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2017-42150

2017-42150

Title 
Director Global Regulatory Affairs
Job Locations 
-
US-Remote
US-NJ
US-NC
US-CA
Posted Date 
11/16/2017

More information about this job

Overview

The Director, Global Regulatory Affairs provides scientific and related regulatory expertise regarding preclinical and clinical research and CMC, as well as  product development support, for either internal customers or external clients, for investigational medicinal products, including chemical entities, biologicals, biotech products, advanced therapies and medical devices. Participates in project teams or may provide service as an independent expert.  Provides regulatory strategy, due diligence, regulatory scientific review of regulatory submissions - NDA/BLA, IND, MAA, CTA, CTD, NDS submissions etc. Leads and coordinates Agency/authority interactions for multiple projects. Provides functional management to the regulatory affairs department staff.    
 

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

Qualifications

  • Minimum of 12+ years prior Regulatory Affairs experience in drug development and registration activities. 
  • Prior experience of working with global clinical trials.
  • Progressive experience in US, Canadian and European regulatory liaison environment essential, other jurisdictions desirable
  • Direct experience with regulatory agency negotiation and meetings 
  • Read write and speak English; fluent in host country language required.
  • Minimum Bsc / BA in related scientific field (e.g. Biology, Chemistry, Pharmacy). Higher degree is preferred. 

 

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

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