Regulatory Affairs Coordinator

Heluna Health•Richmond, CA

1d•$36 - $43

About The Position

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 Coordinator. 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 world wide 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.infantbotliusm.org. The Regulatory Affairs Coordinator 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 related to achieving and maintaining audit readiness. This role will collaborate cross-functionally with internal teams and external stake holders to ensure compliance with regulatory requirements. Employment is provided by Heluna Health. The pay range for this role is $36.00 - $43.00 per hour based on experience.

Requirements

Knowledge of current Good ClinicalPractices (cGCP), current Good Manufacturing Practices (cGMP), Good Documentation Practices and a strong understanding of FDA regulations and guidelines.
Fluency with Microsoft software
Experience with biologics and drug development regulatory affairs
Effective communication, problem-solving ability, collaborative, demonstrating initiative, flexibility
Ability to read, understand and follow written instructions accurately, consistently and repeatedly
Minimum of 3 years of experience in regulatory affairs or clinical research

Nice To Haves

Experience with infectious diseases preferred
Experience with LEAN or equivalent quality improvement framework
Experience with regulatory registration of products is desired
Knowledge of botulinum toxin, infant botulism and its treatment preferred
Regulatory Affairs Certification n(RAC), Certified Clinical Research Professional (CCRP,)CCRA or CCRC or ACRP-CP ACRP-CP Certification ACRP preferred

Responsibilities

Produce well prepared meetings, communications, and effective decision support leading to adoption of achievable strategies to advance regulatory compliance objectives
Participate in review of BabyBIG documentation to support highest possible quality of all records produced by manufacturing contractors or contracting research organizations
Provide support for clinical study maintenance activities (e.g. IRB renewal) and collaboration with clinical study team during active clinical study periods
Collaborate with the IBTPP regulatory team and Compliance Specialist to build an internal system to assess and improve regulatory (GxP) audit readiness
Coordinate and co-design processes for program efforts to streamline the organization, governance, and digitalization of confidential, regulated or other programmatic documents
Facilitate implementation and maintenance of a 21 Code of Federal Regulations (CFR) Part 11-compilant electronic document management system (EDMS)
Draft and/or coordinate finalization of documents tied to regulatory compliance such as standard operating procedures (SOP), SOP attachments and memos to file (MTF)
Other duties as assigned

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