DescriptionAs part of the Global Regulatory Affairs & Patient Safety (GRAPS) department, the
Regulatory Senior Project Manager supports and drives the efficiency and effectiveness of regulatory or cross-functional sub-teams in partnership with the Global Regulatory Lead (GRL) or team lead through meeting management, timeline development / management / tracking, and cross-functional communications.
PM responsibilities may include:Strategy and Execution- Contribute to and support global regulatory strategies and operations, ensuring that they align with program goals/objectives and input of the GRT with functional regulatory representatives
- Track and drive for action item completion
- Partner with GRL and functional regulatory leads to prioritize team activities and manage competing priorities
- Develop regulatory project timelines in collaboration with functional regulatory leads and cross-functional stakeholders; maintain timelines from pre-clinical phase through product life cycle
- Liaise with Project Managers in other functional areas to ensure regulatory timelines are integrated and linked to reflect cross functional dependencies
- Document regulatory milestones/deliverables in the timeline(s) and report progress against team, department and corporate goals as needed
- Prepare project and cross-project dashboards for teams/management, highlighting key regulatory activity such as submission and approval milestones, review periods, etc.
- Track regulatory submissions and approvals globally in the designated tracking system, if applicable for product
- Track and monitor completion of commitments for duration of lifecycle maintenance and ensure timely status updates are made in the designated tracking system, if applicable for product
- In partnership with Global Regulatory Lead (GRL), enforce guidelines of GRT Charter (or other relevant team charters)
Meeting Management & Support - Schedule GRT meetings, generate the agenda and facilitate the meeting (in collaboration with the GRL), and document/distribute minutes (including action items) according to GRT Meeting Best Practices
- Schedule Regulatory Advisory Boards (RABs), facilitate the meeting (in collaboration with the GRL) and document/distribute minutes (including action items) according to RAB Charter
- Provide high-level support to MA/IND/CTA Filing teams (and module teams as applicable)
- For all other meetings (such as Advisory Committee, Paediatric Investigation Plan (PIP), or ad hoc), PM may document decisions and/or action items as needed
Cross-functional Leadership - Liaise across regulatory teams, sub-teams, and cross-functional Filing Teams to ensure consistent communication and alignment
- Communicate regulatory information and activities to stakeholders outside of regulatory and externally
- Partner with various stakeholders to transition products from development to marketed stage
- Represent Regulatory on Production Integration Management Team (PRIME) and align on deliverables/timeline with cross-functional PMs; provide input on regulatory activities in the product dashboards created by the PRIME teams
- Identify and implement opportunities for process improvement within GRAPS
Competencies:- Decision Making and Problem Solving
- Influence, Cross-Functional Collaboration and Organizational Awareness
- Agility and Proactivity
- Leadership
- Communication
- Strategic Thinking and Planning
- Project Management
- Team and Stakeholder Management and Communication
- Drug Development and Product Knowledge
- Regulatory Guidances and Processes
- Process Improvement
Education & Experience:- Degree in health or life sciences, including chemistry, molecular biology, or similar; Masters or MBA preferred
- 6+ years with Masters/MBA, 8+ with bachelor's degree
- Project Management in a Biotech or Pharmaceutical Company experience preferred
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Ireland Safety Responsibility
Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
