07 June 2021
Regulatory Affairs Specialist

Regulatory Affairs Specialist 

Company title is  " QA Licensing Specialist" 

Pharmaceutical Manufacturer
Miami/ Ft. Lauderdale Area
On-Site Monday- Friday 8:30 am – 5:30 pm
 
 
Overview
Responsible for activities ensuring compliance with Drug Enforcement Agency (DEA) and Florida Department of Business and Professional Regulation (FL DBPR) regulations including oversight of controlled substance inventories, generation and submission of reports, applications and permits.
 
Experience
  • Bachelor’s degree in a related field from an accredited university with at least 5 years of experience in a pharmaceutical manufacturing environment.
 
 Knowledge, Skills and Abilities
  • Must have experience w/ DEA regulations and guidelines
  • Florida Department of Business and Professional Regulation (FL DBPR) regulations.
  • FDA regulations and guidelines, including cGMPs, related to evaluation of customer complaints and adverse reactions for pharmaceutical products.
  • Pharmaceutical processes, principles, practices, and their application.
  • Business English usage, spelling, grammar, and punctuation
  • Common computer systems and software applications
  • Advanced knowledge of current DEA and GMP regulations (21CFR Parts 210, 211 and 1300) is required.
  • Knowledge of personal computer hardware, software, and databases (MS Office, Trackwise, SAP) is desirable
  • Ability to add and subtract multi-digit negative and positive numbers and to multiply and divide same. Ability to calculate percentage rates, means, modes, and medians
  • Ability to apply common sense understanding to carry out instructions furnished in written, oral and diagram form
  • Ability to deal with problems involving several concrete variables in standardized situations
  • Communicating clearly and concisely, both orally and in writing
  • Ability to read and interpret documents such as operating instructions, procedure manuals, and safety rules
  • Ability to write routine reports and correspondence
  • Ability to speak effectively before groups of customers or employees of organization
  • Establishing and maintaining cooperative working relationships with others
  • Good organizational skills
  • Ensuring compliance with all Company policies and procedures, including safety rules and regulations
 Responsibilities
  • Provides oversight and guidance to the site regarding all DEA matters pertaining to controlled substances and Listed Chemical registrations; quotas; security of and access to DEA storage areas; inventories and inventory reports required by DEA, including initial inventories, biennial inventories, YERS reporting, ARCOS reporting; import and export permits and declarations.
  • Manages DEA form 222 processing in conjunction with procurement, suppliers, and customers. Prepares 222 forms for approval by authorized power of attorney.
  • Prepares and files Arcos reports to DEA and inventory reports to FL DBPR as scheduled.
  • Manages investigation DEA reportable incidents
  • Interfaces with Materials Management, Manufacturing, QC and R&D to determine quantities of controlled substances required. Files quota requests to DEA and monitors usage to assure compliance with approved quotas.
  • Oversees compliance with 21CFR1300 including inventories, security requirements.
  • Develops and maintains procedures governing DEA compliance.
  • Initiates and completes the investigation process for all types of customer complaints
  • Reviews and analyzes documents such as batch records, product release summaries, test data, Variance Investigations, etc. for relationship to the complaint as part of the investigation process
  • Support the Post Market Compliance (PMC) group with the writing, review, and approval of Change Control Reports (CCRs), Deviation Investigations, Customer Complaints, Annual Product Reviews (APRs), and Quality Trend Reports.
 
Compensation
  • $65-$75K annually ( based on experience)  plus 10% bonus, PTO, Paid Holidays, excellent health benefits and more!
 
Apply
Please submit your updated resume in a word document format 
Please make sure your experience in w/ DEA regulations and guidelines; FDA regulations and guidelines, including cGMPs, related to evaluation of customer complaints and adverse reactions for pharmaceutical products are on your resume.
 
If you are a match, you will be contacted by a recruiter from ttg Talent Solution to schedule a phone interview, by email/phone. Please monitor your inbox, voicemail, and junk for messages.