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2017-42900

2017-42900

Title 
Associate Director of Global Reglatory Affairs
Job Locations 
-
Japan
Posted Date 
9/15/2017

More information about this job

Overview

At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community. 

 

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

 

Global Regulatory Affairs department is comprised of 190+ regulatory professionals globally with a wealth of experience working with biopharmaceutical companies, and interacting with regulatory authorities and ethics committees

Responsibilities

As an Associate Director, Global Regulatory Affairs you will provide 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.

 

Your responsibilities will also include:

 

  • 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

The successful candidate will have an undergraduate degree (or equivalent) and experience in either leading projects or leading a team within a regulatory environment. You will have experience in managing clinical trials submissions in accordance with the CT Directive and/or applicable country regulations in a multi-country environment and have the ability to develop methods, techniques and evaluate criteria in a regulated environment. You must demonstrate abilities in scientific creativity and collaboration with others.

 

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

 

PRA Health Sciences is an Equal Opportunity Employer.  We welcome and encourage diversity in the workplace.

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