Regulatory Project Specialist

The Infant Botulism Treatment and Prevention Program (IBTPP) is a unique public health/public service orphan drug program in the California Department of Public Health.  IBTPP is the sole producer and distributor worldwide of the public service orphan drug that it created known as BabyBIG®.

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

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

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

The incumbent will support BabyBIG regulatory activities, provide professional response and service to callers requesting BabyBIG, and will carry out a variety of administrative support functions.

IBTPP is seeking an individual with business experience who is interested in medical research, infectious diseases, and public health.  The position reports to the Regulatory Manager and occasionally works with program technical staff.

The ideal candidate will have business office experience that includes dealing with the public, preferably in medical, biotechnology, or laboratory environments or in pharmaceutical regulatory affairs.

Candidates should have excellent communication skills, both written and spoken, and be able to effectively work in a sometimes fast-paced environment.

Candidates should possess the qualities of professionalism, organization and punctuality. 

The hourly pay range for this role is $30-$38 depending on experience.

ESSENTIAL FUNCTIONS


* Cross train on and master regulatory tasks related to BabyBIG requests tied to distribution, infant botulism epidemiology, and laboratory support needs


* Coordinate BabyBIG-related activities like shipment, materials, and follow-up with vendors; maintain documents and related fiscal record-keeping 


* Assist with regulatory document operations related to BabyBIG development, manufacture, and distribution, such as complying with Standard Operating Procedures (SOP) and support maintaining up to date documents for vendor qualifications such as current confidential disclosure agreements and quality agreements


* Assist with vendor management activities including support for performance of regulatory contracts, BabyBIG distribution incident resolution, procuring subcontracting services, vetting invoices, and projecting program budget needs related to maintaining a supply of BabyBIG 


* Facilitate monthly meetings with BabyBIG shipping and logistics vendors to support continuous quality improvement for BabyBIG shipments and their expedited delivery to ordering hospitals 


* Meet regulatory deliverables tied to BabyBIG inventory tracking and reporting workflows 


* Provide support for program modernization activities such as digitization, maintaining Electronic Document Management System (EDMS), and data analytics and governance


* If ...