What are the responsibilities and job description for the BioTech Regulatory Project Manager position at Akkodis?
Title : BioTech Regulatory Senior Project Manager (PMO)
Opp : Hybrid Contract in San Francisco Bay area
Length : 1 year contract
Hourly Rate : $70.00-$75.00 Depending on Experience
As part of the R&D Project Management Organization (PMO), 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 Affairs 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)
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit
The Company will consider qualified applicants with arrest and conviction records.
Salary : $70 - $75
