Regulatory Project Manager 2
San Rafael, CA
Who We Are From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. As part of the Global Regulatory Affairs organization, the Regulatory Project Manager 2 supports and drives the efficiency and effectiveness of the Global Regulatory Team (GRT), Regulatory Strategy Meetings (RSMs), and Regulatory or cross-functional sub-teams such as Health Authority (HA) meeting teams or Marketing Application/Investigational New Drug/Clinical Trial Application (MA/IND/CTA) filing teams, as appropriate, in partnership with the Global Regulatory Lead (GRL) or team lead through meeting management, timeline development / management / tracking, and cross-functional communications.\u00A0Responsibilities may include:\u00A0Plan, Execute, and Monitor Support global Regulatory Affairs strategies and operations, ensuring that they align with program goals/objectives. This alignment requires input and support of the GRT with functional regulatory representatives owning their respective deliverables and regional responsibilities 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 to reflect cross functional dependencies; work with Global Project Manager (GPM) to ensure dependent tasks are linked Prepare project and cross-project dashboards for teams/management, highlighting key regulatory activity such as submission and approval milestones, review periods, etc. 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 Strategy Meetings (RSMs), facilitate the meeting (in collaboration with the GRL) and document/distribute minutes (including action items) according to Regulatory Strategy Meeting Best Practices 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 neededCross-functional Leadership Liaise across all Regulatory teams and sub-teams to ensure consistent communication and alignment Communicate regulatory information and activities to stakeholders outside of regulatory (including external stakeholders) Partner with various stakeholders to transition products from development to marketed stage Within the GRT/sub-teams, foster a culture that promotes respect, teamwork, collaboration, openness, and appreciationCompetencies: 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 ImprovementEducation & Experience: Degree in health or life sciences, including chemistry, molecular biology, or similar; MBA preferred 4 years with MBA, 6 with bachelor\u2019s degree Project Management in a Biotech or Pharmaceutical Company experience preferred PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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