Senior Global Regulatory Affairs Project Manager

Purpose

Support planning, execution and follow-up of timelines and resources for GRA regulatory filings through product development and life-cycle management

Main Responsibilities

Project Coordination
- Collaborate with Operational Excellence team members to execute regulatory project coordination and management, including agile ways of working, within GRA utilizing common templates and project plans.
- Support the Therapeutic Areas (TAs) by assisting with the management, and tracking of specific deliverables within GRA, including but not limited to INDs, NDAs, BLAs/MAAs and major variations, working with cross-functional teams.
- Align with Project and Portfolio Management (PPM) to identify key milestones for GRA to meet business objectives, from clinical trial initiation, regulatory submission, approval, and post-approval life cycle management.
- Support internal initiative(s) with a goal to accelerate internal regulatory processes and subsequently development timeline
- In collaboration with the GRA Global Regulatory Leads and/or the GRA Regulatory Managers and Specialists, support the following activities:
  o    Track GRA project related costs to ensure alignment with overall project budgets.
  o    Ensure roles and responsibilities within submission teams are clearly defined.
  o    Cross functional submission team meetings to drive decision making and project execution; help in the creation of agendas, meeting minutes, and tracking/resolution of action items.
- Ensure overall GRA project timelines are aligned cross-TA / cross-functional teams and support the coordination of timely regulatory submissions.
- Identify and recommend solutions for timeline concerns or obstacles, including risks and issues, engaging appropriate leads for mitigation and resolution.
- Coordinate projects which impact more than one TA; setting up and leading cross-TA / cross-functional teams as applicable
- Assist with special projects within Regulatory Operations and Digital as needed.

Experience Required

5 years in Regulatory with good knowledge of drug development and regulatory procedures

Education

At least Bachelor’s Degree in Life Sciences

Languages

Fluency in english 

Technical Skills

Knowledge of regulatory strategy and dossier development, evidence of successful regulatory operations management