Senior Associate, RA GRPT, Regulatory Strategic Planning

Lake County, Illinois, USA
Apr 12, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Senior Associate, Regulatory Strategic Planner (RSP) is responsible for project management support of low to medium complexity Global Regulatory Product Teams (GRPT) in coordination with Global Regulatory Lead (GRL). These teams are led by the GRL, and are comprised of global cross-functional regulatory professionals that develop regulatory strategy for development and marketed products. In partnership with the GRL and their supervisor, the RSP will manage the teams meetings with its associated minutes, and a project plan with its associated reports. They will also manage the teams proactively to operate in compliance with regulations and company policies and procedures, and guidance's within Quality Dossier Program (QDP) and GPS/RSP.
Key Responsibilities Include:
  • Accountable for ensuring that team goals are met
  • With managers support, provides operational and procedural leadership and coordination to the GRPT, and drives GRPT operations in support of the GRL
  • Manages GRPT and related meetings (e.g. Global Regulatory Forum, Dossier Team,
  • Rapid Response Team, Regulatory Advisor Panel, Partner, etc.) by executing:
    Meeting calendaring
    Action items and follow-ups
    Team Communications
  • Establishes and maintains the GRPT SharePoint Teamsites and other related QDP teamsites (Dossier Team and Rapid Response Team) for team and project information.
  • In partnership with GRLs and under guidance of supervisor, manages the preparation and maintenance of GRPT Project Plans for assigned products.
  • Establishes and maintains an integrated GRPT Project Plan for the team and uses the GRPT Project Plan Template and related guidance's
    Manages a MS Project Plan file in MS Project Server
  • Uses Qlikview and Visibility Swimlane tools for reporting
  • Manages and drives documentation processes for GRPTs including:
    i) GRPT Charter
    ii) GRPT Team Rosters
    iii) Global Regulatory Strategic & Tactical Plan (gRSTP)
    iv) GRPT Project Plan Reports, Forecasts and Dashboards
    v) Global RA Monthly Reports
    vi) Risk and eCTD Dashboards
    vii) Lead and participate in continuous improvement initiatives within GPS/RSP to support GRPTs.
  • Provides Therapeutic Area Heads support with portfolio oversight, budget and contract maintenance, and functional activities
  • Under supervision, advises internal personnel on regulatory tactics.
  • Follows company policies and procedures for regulatory record keeping.
  • Regularly informs regulatory management of important timely issues and the impact on the global program.
  • Under direction of supervisor, provides executive management with meaningful regulatory measurements and regulatory opinion.
  • Follows budget allocations and keeps supervisor informed on project resourcing
  • High school diploma or equivalent and 4 years industry related experience
  • 5 years pharmaceutical or industry related experience
  • 5 years' of project management or related experience
  • Experience working in complex and matrix environment
  • Strong communication skills both oral and written
  • Bachelor's degree Project Management-related certifications a plus
  • 2 years' experience in regulatory affairs 2 years project planning and management experience, including successful implementation of business and technology initiatives training and/or experience with process modeling tools

Note: Higher education may compensate for years of experience

Equal Opportunity Employer Minorities/Women/Veterans/Disabled