Regulatory Compliance Implementation Associate

Heluna Health and the Infant Botulism Treatment and Prevention Program (IBTPP) of the California Department of Public Health (CDPH) invite applications for the position of Regulatory Affairs Compliance Associate.

IBTPP is a unique public health/public service orphan drug program in the California Department of Public Health.

IBTPP is the creator, sponsor, producer and distributor worldwide of the licensed public service (i.e., not-for-profit) orphan drug, BabyBIG®.

BabyBIG treats the orphan (rare) disease known as infant botulism, a life-threatening, paralytic, infectious illness of babies.

The program interacts with federal and state government agencies, private contractors, hospitals, physicians, and infant botulism families nationwide.

The IBTPP consists of a small team of dynamic, dedicated professionals who work on the diagnosis, treatment and prevention of infant botulism.

Additional program information may be found at: www.infantbotulism.org.

The Regulatory Compliance Implementation Associate will report to the IBTPP Regulatory Manager and provide professional support to the regulatory and compliance activities of the program.

The incumbent will also take direction from the IBTPP Compliance Specialist for the successful accomplishment of activities directed towards achieving and maintaining audit readiness.  This role will collaborate cross-functionally with internal teams and external stakeholders to ensure compliance with regulatory requirements.

Pay rate: $36 - 43 per hour

ESSENTIAL FUNCTIONS


* Implement strategies to meet regulatory and compliance objectives for a public health/public service program, provide accompanying decision support for IBTPP leadership, and reliably put agreed upon strategies into action


* Facilitate implementation and maintenance of a 21 Code of Federal Regulations (CFR) Part 11-compliant electronic document management system (EDMS)


* Management of paper/physician records associated with clinical studies and the manufacture of BabyBIG and conversion of paper/physical records to electronic records


* Collaborate with the IBTPP Compliance Specialist to build an internal system to assess and improve audit readiness for past and present clinical studies and commercial lots of BabyBIG


* Co-design processes to streamline the organization, governance, and digitalization of confidential, regulated or other programmatic documents 


* Track mandatory staff training, compliance learning and certifications by staff role 


* Build and contribute subject matter knowledge of relevant FDA or other regulatory body’s (e.g.

Institutional Review Board) regulations, guidance documents, and reporting requirements  


* Support the review processes for regulatory Standard Operating Procedures 


* Other duties as assigned

JOB QUALIFICATIONS


* Knowledge of current Good Clinical Practices (cGCP), current Good Manufacturing Practices (cGMP), Good Documentation Practices and a st...