Senior Mgr/Associate Director Regulatory Program Manager
Sr.Manager/Associate Director: Regulatory Program ManagerAllakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:As a member of the Allakos team you will have the opportunity to serve a key role in setting schedules, establishing business processes, and supporting the team during the preparations. The initial focus will be on assembly and completion of the BLA for lirentelimab but the Sr Program Manager will also have responsibility to support additional regulatory initiatives and submissions. The Sr. Regulatory Program Manager reports directly to the Sr. Director. Regulatory Affairs supporting on-time submission of important regulatory filings. The Sr Program Manager will play a key role in integrating work across multiple workstreams with aggressive timelines. This role will require a candidate who is comfortable working collaboratively with teams who also enjoys providing hands-on program management support for building and managing detailed project schedules. Your Role:
- Work closely with the Sr. Director of Regulatory Affairs to capture and establish the detailed schedule for drafting, review and completion of the BLA.
- Establish right -sized and scalable business processes in regulatory affairs and agreed by stakeholders.
- Maintain the project schedule and track performance against agreed milestones
- Partner with project managers from across the organization to ensure key documents, reports, and regulatory sections meet content, timing, and review criteria.
- Identify issues and implement appropriate and timely mitigation plans.
- Organizes, plans and chairs the regulatory PM meetings. Drives the agenda and sends out pre-reads.
- Support the conduct of regulatory meetings, with agendas, minutes, and action item follow-up.
- Prepare presentations for various forums.
- Serve as PM for new regulatory planning initiatives.
- At least 5 years of experience in regulatory affairs or working directly in support of regulatory submissions
- At least 5 years of experience in Project Management (PMP certification a major advantage)
- Demonstrated ability to lead a team
- Regulatory or technical writing experience preferred
- Demonstrated understanding of the elements required for successful regulatory submissions
- Excellent communication, time and project management skills and ability to champion the CMC strategy