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.
- 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.
- 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.