Manages the corporate regulatory affairs responsibilities, including regulatory licensing and VAWD accreditation of all of CareTria's warehouse facilities. Oversees various administrative functions performed by the Compliance Coordinator for the department.
KEY RESPONSIBILITIES:
Regulatory:
Overall responsibility for compiling regulatory submissions to the Federal and State agencies, drafting submissions to include client Product Information, CareTria Facility Information, literature searches to support corporate submissions, client and/or government agency notification and other regulatory activities.
Manages the renewal and maintenance of CareTria's federal and state distributor licenses for all CareTria's warehouse locations including the preparation of supporting documents for new and renewal licenses for submission to state licensing agencies
Submits requests to Finance for payment for all licenses, permits and other required regulatory agency filings
Maintains RA and QA departments expenditure documentation including reports to Finance
Responds to requests and queries; serving as liaison with state regulatory officials in connection with licensing matters under the supervision of the Vice President of Regulatory Affairs and Compliance
Stays abreast of regulatory updates and changes in license filings as they affect CareTria's warehouse facilities
Manages surety bonding requirements to ensure CareTria maintains compliance with all applicable state licensing agencies
Assists in the research and interpretation of state and regulatory regulations/rules related to wholesaler, third-party logistics provider and business licensing requirements
Conducts regulatory research and assists the Compliance Manager and Compliance Analysts with updates to Knipper’s mid-level prescriptive authority table
Manages the updates to Knipper’s wholesaler regulation database for CareTria warehouse facilities
Assists with client audit questionnaires and compilation of responses to audit reports
Assists with re-accreditation of CareTria by the National Association of Boards of Pharmacy for all warehouse locations, which includes annual compliance evaluations for all facilities
When necessary, assists the Compliance Training Manager and/or QA with tracking, scheduling and coordinating internal PDMA and cGMP training
When necessary, assists in the coordination of Client Compliance/CIA Training
Prepares Knipper and client FDA, DEA and state submissions for Loss/Theft Reporting and other compliance violations
Arranges all appointments and meetings for the Regulatory Affairs and Compliance department using own judgment; resolve telephone requests directly or through appropriate resource
Maintains Regulatory Affairs and Compliance files
Contacts state boards of pharmacy to facilitate manual adjudication for CareTria prescriber validation program
Assists Vice President, Regulatory, Compliance and QA with projects and follow up as needed
Document archiving as required
The above duties are meant to be representative of the position and not all-inclusive.
MINIMUM JOB REQUIREMENTS:
Education/Training: Associates Degree plus five years legal or compliance administrative work experience or comparable years of experience.
KNOWLEDGE, SKILLS & ABILITIES:
Knowledge of pharmaceutical industry, including drug storage and distribution
Knowledge of inspection process for drug sample distribution
Strong knowledge of PDMA and DSCSA
Experience working on regulatory submissions Excellent communication skills, written and verbal Ability to understand and communicate legal risk
Computer skills: Proficient in MS Office, Excel, and Word; basic understanding of data processing, ability to learn new business and warehouse management software/systems
Excellent communication, organizational and data entry skills
Detail oriented and has computer knowledge and good customer service awareness
Notary Public
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The expected base pay range for this position is $90,000-$95,000 per year. The actual compensation for the position may vary based on market differences and on factors such as skills, experience, qualifications and can vary based on location and/or work schedule. In addition to base pay, CareTria offers a comprehensive benefits package. Full-Time benefits include access to health, dental, and vision insurance; retirement plan options; paid time off; paid parental leave; employee assistance programs; and other perks. Eligible employees may also have access to performance bonuses.
CareTria is an equal opportunity employer