San Mateo Metro Area, CA
- Support day-to-day regulatory activities of assigned projects including preparation and compilation of submissions for regulatory agencies, management of regulatory submissions processes and timelines, and regulatory tracking tools, archives, and infrastructure.
- Manage document archive processes.
- Provide support to routine and maintenance submissions.
- Bachelor degree in Life Sciences preferred.
- Relevant pharmaceutical industry experience including experience in Regulatory Affairs.
- Knowledgeable of international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
- Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.