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. notforprofit) orphan drug BabyBIG. BabyBIG treats the orphan (rare) disease known as infant botulism a lifethreatening 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: .

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 crossfunctionally 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 11compliant 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
• Codesign 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 bodys (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 problemsolving 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 ACRPCP ACRPCP Certification ACRPpreferred

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.

Required Experience:

IC