Senior Manager Regulatory Affairs

FLSA Classification : Exempt/Salary 

Schedule: Monday – Friday; 8:00 am to 5:00 pm 

Department: Regulatory Affairs - US 

Reports to: US Senior Director Regulatory Affairs 

Supervisory responsibilities: No 

Location: Fully Remote or On-site at 13203 Murphy Rd. Suite 100, Stafford, TX 77477 

Position Summary/objective: 

Immatics is a clinical-stage biopharmaceutical company developing novel immunotherapies against cancer. We combine the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. Our goal is to provide cancer patients with innovative and effective treatments. 

We are seeking a highly motivated and detail-oriented Senior Manager, Regulatory Affairs, to join our US Team.  The successful candidate will support Regulatory Project Leads in both Clinical and CMC aspects of drug development.  The ideal candidate will have direct experience within a regulatory function and a desire to grow into a strategist role.  Experience with cell and gene therapies or biologics in the oncology therapeutic area is a plus. 

Essential functions: 

• Take responsibility for routine submission content (e.g., 1572 updates, 1572 waiver requests) and distribution of waiver granted letters for TMF filing 

• Assist Regulatory Project Leads with tracking regulatory commitments, deliverables, submissions, reviews, and overall project timelines 

• Support Regulatory Project Leads with ensuring content and quality of regulatory documentation, including QC checks of submission packages 

• Collaborate closely with cross-functional team members to achieve timely submissions and approval/clearance of amendments. 

• Review and provide feedback on packages to enable clinical study startup and assist in responding to clinical site queries 

• Support with responses to FDA Requests for Information as needed 

• Support annual document updates (DSUR, IB, Orphan Drug Annual Report) 

• Support Regulatory Project Leads in gathering regulatory precedent information from approved products 

• Provides initial submission and periodic updates regarding clinical studies to clinicaltrials.gov 

Secondary functions: 

• Review, authoring, and editing of SOPs that include Regulatory Affairs responsibilities as assigned 

• Supports regulatory document archiving and tracking databases 

 Competencies: 

• Demonstrated capacity of applying Regulatory Affairs, Clinical, CMC, Quality, and Nonclinical information to support overall product development 

• Demonstrated ability to work in a cross-functional team environment 

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