Sr. Regulatory Associate/Manager, Regulatory Affairs

Location
94080, South San Francisco
Posted
Jun 09, 2021
Required Education
Bachelors Degree
Position Type
Full time

Harpoon Therapeutics is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for small cell lung cancer and other DLL3-associated tumors. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.

 

The primary role of this position is to provide regulatory support for the clinical development of Harpoon Therapeutics products from early phase clinical trials to worldwide submission and approval.

Specific responsibilities include:

  • Coordinate the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for submission to Health Authorities (INDs, CTAs, amendments, annual reports, meeting packages, etc.)
  • Lead the regulatory aspects of ICF review, new investigator submissions, annual reports, and pharmacovigilance-related submissions (e.g., PSURs/DSURs) as needed including preparation of cover letters and forms
  • Ensure that the quality, accuracy, and format of regulatory submissions and other documentation comply with applicable laws, regulations and standards
  • Coordinate with publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring conformance with submission standards
  • Maintain compliant logging, tracking, and filing of submissions and correspondence with regulatory authorities
  • As assigned, perform literature searches, prepare special reports, and assemble documentation to support project teams
  • Maintain knowledge of global regulatory environment, regulations, and guidelines
  • Participate in cross-functional subteams and working groups
  • Maintain records for and occasionally lead Regulatory focused meetings
  • Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures

 

Minimum Education/Experience

  • Bachelor’s degree (or equivalent) in life sciences, Graduate Degree preferred
  • 3+ years of experience in the pharmaceutical industry, direct experience in regulatory affairs or related function preferred

 

Other Qualifications

  • Fundamental understanding of GxP
  • Good understanding of clinical development of novel therapeutics, with a focus on the IND process
  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment to meet aggressive timelines
  • Self-motivated, self-disciplined, and able to function independently as well as part of a team
  • Excellent computer proficiency (MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document management systems)
  • Experience with eCTD publishing systems advantageous