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.
- 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.
- 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.