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 regulatory authority interactions, communications, and submissions; 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

  • Support planning, preparation and review of regulatory submissions for INDs/CTAs, BLAs, meeting requests and briefing documents, including ammendments and annual reports to FDA, and other regulatory authorities.
  • Ensure that the content and format of regulatory submissions and amendments are in compliance with all applicable regulations and guidelines.
  • Review protocols, consent forms, R&D reports and scientific documents, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
  • Develop and implement regulatory project time lines that align with corporate goals.
  • Provide strategic regulatory guidance to internal and external stakeholders.
  • 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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