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 strong understanding of FDA regulations and guidelines.
• Fluency with Microsoft software
• Experience with biologics and drug development regulatory affairs
• Experience with infectious diseases preferred
• Experience with LEAN or equivalent quality improvement framework
• Effective communication, problem-solving ability, collaborative, demonstrating initiative, flexibility

Education/Experience

• Minimum of 3 years of experience in regulatory affairs or clinical research
• Experience with regulatory registration of products is desired
• Knowledge of botulinum toxin, infant botulism and its treatment preferred

Certificates/Licenses/Clearances

• Regulatory Affairs Certification (RAC), Certified Clinical Research Professional (CCRP), CCRA or CCRC or ACRP-CP ACRP-CP Certification - ACRP preferred

ADDITIONAL INFORMATION

This position may require travel within the state of California to confer with Heluna Health, CDPH staff, or regulatory contractors. When necessary, the incumbent must be able and willing to travel.

PHYSICAL DEMANDS

• Stand: Frequently
• Walk: Frequently
• Sit: Frequently
• Handling / Fingering: Frequently
• Reach Outward: Occasionally
• Reach Above Shoulder: Occasionally
• Climb, Crawl, Kneel, Bend: Occasionally
• Lift / Carry: Occasionally - Up to 50 lbs
• Push/Pull: Occasionally - Up to 50 lbs
• See: Constantly
• Taste/ Smell: Not Applicable

KEY

Not Applicable = Not required for essential functions

Occasionally = (0 - 2 hrs/day)

Frequently = (2 - 5 hrs/day)

Constantly = (5+ hrs/day)

WORK ENVIRONMENT

General Office Setting, Indoors, Temperature Controlled

EEOC STATEMENT

It is the policy of Heluna Health to provide equal employment opportunities to all employees and applicants, without regard to age (40 and over), national origin or ancestry, race, color, religion, sex, gender, sexual orientation, pregnancy or perceived pregnancy, reproductive health decision making, physical or mental disability, medical condition (including cancer or a record or history of cancer), AIDS or HIV, genetic information or characteristics, veteran status or military service.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.