Hybrid Regulatory Project Manager – FSP, Advanced MS Project User

at Thermo Fisher Scientific

• Job title: Regulatory Project Manager – FSP, Advanced MS Project User
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Belgium

About the role

• Regulatory Project Manager driving submission projects in partnership with Regulatory Leads and cross-functional teams. Creating and maintaining operational regulatory submission plans to ensure alignment and compliance.

Responsibilities

• The RPM partners with PM and Regulatory Leads as applicable and consults other Submission Team members to create an integrated and dynamic operational regulatory submission plan in support of projected global regulatory approval for assigned asset(s) in targeted regions, and therapeutic indications and/or presentations per corporate strategy;
• Scenario planning taking into account all submission activities that rely on resources needed for assigned submission plans;
• Creates visuals, reports to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders; anticipates delays and mitigates impact to timelines;
• Ensures submission team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities and meets target submission dates;
• Enables function leads to ensure that all documents are prepared with global Regulatory/ Health Authority quality standards;
• Leads submission planning discussions incl., setting agendas, minutes and follow up on key actions with stakeholders;
• Works with functional teams to identify ways to optimize and accelerate submission timelines;
• Partners with PMs to ensure submission project plan and cross-functional project plans are aligned and optimized;
• Manages submission planning meetings, including agenda preparation, minutes taking, communication of decisions; tracking and resolution of action items;
• Translates post-submission requirement into an executable post-submission plan;
• Identifies any issues, risks, or impact due to changes in strategy and/or timelines throughout the submission process;
• Identifies key learnings & best practices and shares lessons learned across programs in order to refine and improve submission processes;
• Contributes to the development of the Project Community Centre to share best practices and tools across Project Management community;
• Leads and/or participates in cross-functional and functional workstreams/initiatives

Requirements

• Requires a Master’s degree (or foreign equivalent) in Regulatory Affairs, Pharmaceutical Studies or a directly related biotechnology field with at least 2 years of Regulatory Project Management experience
• Experience must include three (3) years of experience in the following (experience may be gained concurrently):
• o Drug development experience within the distinct phases of development, in different disease areas;
• o One (1) year of experience in the following (experience may be gained concurrently):
•  Program Management experience within a regulated Pharmaceutical or Biotech environment;
•  Creating and maintaining Global submission plans to be compliant with regulatory timelines and capturing eCTD content and associated activities;
•  Pharma R&D;
•  Drug development project management using MSP; experience with One-pager Pro, Planisware and PowerBI is a plus;
•  Experience in development of biologicals and rare diseases

Benefits

• competitive salary
• extensive benefits package
• flexible working culture
• award-winning learning and development programme