AbbVie Sr. Manager, RA GRPT, Regulatory Strategic Planning in Lake County, Illinois

Description:
The Senior Manager Regulatory Affairs, Global Product Strategy also known as the Regulatory Strategic Planner (RSP) is responsible for project management support of Global Regulatory Product Teams (GRPT) in coordination with Global Regulatory Lead (GRL). Manages the teams’ meetings with associated minutes, and a project plan with associated reports. Manages 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. Manages compounds through all phases of clinical development and post approval life cycle activities. Participates in and may lead continuous improvement initiatives. Acts under the direction of the supervisor and is accountable for ensuring that individual goals are met. Provides GRPTs project management support that drives implementation of strategies, meetings, communications and information sharing. * Provides operational and procedural leadership and coordination to the GRPT, and drives GRPT operations in support of the GRPT. * Manages the GRPT and related meetings (Global Regulatory Forum, Dossier Team, Rapid Response Team, Regulatory Panel, Partner, etc.) by executing: Meeting calendaring, Agendas, Minutes, Action items and follow-ups and 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 * 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: GRPT Charter, GRPT Team Rosters Global Regulatory Strategic & Tactical Plan (gRSTP), GRPT Project Plan Reports, Forecasts and Dashboards Global RA Monthly Reports, Risk and eCTD Dashboards * Participate in and may lead continuous improvement initiatives within GPS/RSP to support GRPTs. * Under supervision, advises internal personnel on regulatory tactics. Follows company policies and procedures for regulatory record keeping. Under supervision, 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. * Project manages a few to several GRPTs and proactively plans for and drives the teams to develop and execute strategies and tactics for development and marketed products. * In partnership with GRLs, manages the teams to operate within operational guidance’s. * In addition, escalates appropriately team issues and risks to, and seeks expert advice and technical support when necessary from supervisor, RSPs, GRLs, GPS leadership and other personnel when required.

Qualifications:

Required:

  • 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 complexity and matrix environment
  • Strong communication skills both oral and written Preferred:
  • 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

Job Classification: Experienced
Job: REGULATORY AFFAIRS
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Schedule: Full-time
Shift: Day
Travel: Yes, 5 % of the Time
Req ID: 1703858

Equal Opportunity Employer Minorities/Women/Veterans/Disabled