Regulatory Project Manager

Akkodis is hiring a Regulatory Senior Project Manager to support our client in the BioTechnology industry. This role will drive the efficiency and effectiveness of Regulatory affairs through meeting management, timeline development / management / tracking, and cross-functional communications.Employment type: 1 year contract with potential for FTE conversionLocation: Hybrid (2 days in office in San Ramon, CA)Pay: $60-70/hrPM responsibilities may include:Strategy and ExecutionContribute to and support global Regulatory Affairs strategies and operations, ensuring that they align with program goals/objectives and input of the GRT with functional regulatory representativesTrack and drive for action item completionPartner with GRL and functional regulatory leads to prioritize team activities and manage competing prioritiesDevelop regulatory project timelines in collaboration with functional regulatory leads and cross-functional stakeholders; maintain timelines from pre-clinical phase through product life cycleLiaise with Project Managers in other functional areas to ensure regulatory timelines are integrated and linked to reflect cross functional dependenciesDocument regulatory milestones/deliverables in the timeline(s) and report progress against team, department and corporate goals as neededPrepare 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 productTrack 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 productIn partnership with Global Regulatory Lead (GRL), enforce guidelines of GRT Charter (or other relevant team charters)Meeting Management & SupportSchedule 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 PracticesSchedule Regulatory Advisory Boards (RABs), facilitate the meeting (in collaboration with the GRL) and document/distribute minutes (including action items) according to RAB CharterProvide 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 LeadershipLiaise across Regulatory teams, sub-teams, and cross-functional Filing Teams to ensure consistent communication and alignmentCommunicate regulatory information and activities to stakeholders outside of regulatory and externallyPartner with various stakeholders to transition products from development to marketed stageRepresent Regulatory Affairs 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 teamsIdentify and implement opportunities for process improvement within Regulatory Affairs and the PMOEducation & Experience:Degree in health or life sciences, including chemistry, molecular biology, or similar; Masters or MBA preferred6+ years with Masters/MBA, 8+ with bachelor's degreeProject Management in a Biotech or Pharmaceutical Company experience preferredEqual Opportunity Employer/Veterans/DisabledBenefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a clientTo read our Candidate Privacy Information Statement, which explains how we will use your information, please visit Company will consider qualified applicants with arrest and conviction records.

Created: 2025-02-19