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.

ESSENTIAL FUNCTIONS

• 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

JOB QUALIFICATIONS

• 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
• Experience with infectious diseases preferred
• Experience with LEAN or equivalent quality improvement framework
• Effective communication, problem-solving ability, collaborative, demonstrating initiative, flexibility
• Ability to read, understand and follow written instructions accurately, consistently and repeatedly

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

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

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

APPLICATION PROCEDURES

Interested applicants should submit a resume and cover letter for consideration.

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.