Regulatory and Compliance Specialist

Regulatory and Compliance Specialist Job Description

 

Summary

The Regulatory and Compliance Specialist is responsible for initial new product assessment, confirming authorized distributors, NDC assignment, Structured Product Labeling (SPL’s), DEA Arcos Reporting, DEA Class II Quota, FDA registrations, Licensing and reporting.

 

General Duties and Responsibilities:

 

• Responsible for maintaining an accurate database of the status of all NDC’s currently assigned and assign new NDC’s as necessary.
• Own new product review process to include manufacturer, and product approval, SPL required information, PPE requirements, required cleaning validation rating, hazardous waste impact and safety concerns.
• Ensure receipt of current authorized distributor of record (ADR) certificates from all product suppliers
• Prepare Structured Product Labeling (SPL) for new products and communicate cross functionally of posted SPL’s.
• Review ongoing product labeling to ensure compliance.      
• Maintain current knowledge of current SPL related regulations and requirements and communicate same to appropriate stakeholders
• Responsible for electronically reporting all potential FAERS adverse events
  • Prepares and submits all required FDA and regulatory reports including: GDUFA, Establishment Registration and SPL Annual Certification.
• Responsible for maintaining data on all controlled substances as required for quarterly and annual DEA Arcos submissions
• Prepare and submit DEA Form 106 for potentially lost/stolen controlled products
• Completes and submits data required for the U.S. Dept. of Commerce Census Report
• Monitor/renew state licenses (Wholesale/Manufacture/Controlled) as required
• Identify modifications for all required licenses and/or registrations in order to maintain corporate compliance with all pertinent agencies
• Prepare Foreign Corporation Registration and annual report submissions for each required state
• Maintain current knowledge of regulatory requirements/changes that impact GSMS and communicate to GSMS Management
• Responds to and interfaces with Regulatory Body as required
• Participates in, and provides support as needed to other regulatory affairs, regulatory compliance activities as the relate to the department and the company as a whole
• Read, understand and abide by written instructions and SOPs.

 

Physical/Cognitive Requirements:

 

• Unquestioned integrity and strong business ethics
• Exceptional interpersonal and communication skills
• Ability to work independently with minimal direction
• Skilled at comprehending and analyzing technical documentation
• Time management skills
• Highly detailed with tactical orientation
• Proven problem-solving skills and track record of delivering results
• Highly motivated, high energy and goal-driven
• Ability to work in a team setting
• Excellent listener
• Proficiency with Microsoft Office applications required
• Must be able to move freely throughout the campus
• Must have the ability to use a keyboard and view a computer monitor for long periods of time

 

Supervision:

• Received: Associate Director, Quality and Compliance
• Given: None.

 

Education:

 

Bachelor’s degree or 5 years or more of pharmaceutical regulatory experience required

RAC (Regulatory Affairs Certification) desirable

 

 

Miscellaneous Requirements:

Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies.

“At Golden State Medical Supply (GSMS), we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.  If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at [email protected]. GSMS will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.”