Career Opportunities

Specialist: Regulatory Affairs

St. Louis, MO / San Diego, CA

Wugen, Inc. is a clinical-stage biotechnology company developing novel “off-the-shelf” Memory NK and CAR-T cell therapies for the treatment of cancer.  Our Immuno-oncology therapies address the unmet need of patients with solid tumors and hematologic malignancies. Our transformative platform provides a distinct set of advantages over other immune cells commonly used for cell therapy. We have premier research facilities in St. Louis, MO and San Diego, CA. Come join us in our pursuit to eradicate cancer. To learn more about us, please visit www.wugen.com and follow us on LinkedIn.

Job Description

Wugen Inc. is seeking exceptional and highly motivated candidates to join our teams in San Diego and St. Louis. This candidate will be responsible for providing regulatory support for clinical-stage projects. This includes providing regulatory guidance to cross-functional teams; supporting the preparation, review and submission of documents to regulatory authorities; and reviewing project documentation to ensure compliance with applicable regulations and guidelines. The level of the position and compensation package will be competitive and commensurate with experience.

Primary Responsibilities

  • Assist with activities of the Regulatory Affairs Department and GXP activities, including CMC, clinical, and non-clinical documents.
  • Prepare and execute regulatory submissions (INDs/CTAs, BLAs, meeting requests and briefing documents, amendments, annual reports and safety reports) and assist with international submissions.
  • Assist in review and approval of clinical protocols, consent forms, R&D reports and scientific documents, etc., as appropriate for clinical trial start-up and maintenance, ensuring compliance with regulations.
  • Assist in the collection, tracking, and review of regulatory and clinical trial site documents.
  • Maintain regulatory document submission files, registry, and tracking systems.
  • Interface with CMC, R&D and clinical research teams and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities.
  • Coordinate with third party consultants and CROs to supplement expertise and operational capacity.
  • Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents.

Preferred Qualifications

  • Bachelor’s or advanced degree in science with 2+ years of experience in Regulatory Affairs within the biotech/pharmaceutical industry.
  • Direct experience and knowledge in preparation of INDs/CTAs and amendments.
  • Working knowledge of FDA/ICH GMP, GLP, and GCP regulations/guidelines, as well as understanding of the pharmaceutical product life cycle.
  • Detail oriented with strong organizational and communication skills.
  • Self-motivated with ability to work independently and operate effectively within an entrepreneurial fast-paced, collaborative work environment.
  • Strong knowledge in standard software including Word, Excel, and PowerPoint.

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