Regulatory Compliance Specialist

1 month ago

Spring Valley, New York, United States Strides Pharma Inc Full time
Job Title: Regulatory Compliance Specialist

Strides Pharma Inc is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our compliance team, you will be responsible for ensuring that our company's operations are in compliance with all relevant regulations and laws.

Key Responsibilities:
  • Manage and coordinate all DEA-related activities at our site
  • Review and release daily orders through the Suspicious Order Monitoring System (SOMs) and ensure compliance with Suspicious Orders Reporting (SORS)
  • Maintain Know your Customer (KYC) information
  • Conduct year-end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA website
  • Coordinate all movement of controlled substances from manufacturing through analytical testing
  • Liaise with Procurement and DEA regarding import/export of controlled substances and complete necessary paperwork
  • Maintain compliance of all DEA, State, and Board of Pharmacy registrations
  • Coordinate all controlled substance destruction with QC, Environmental, Health & Safety, and Logistic departments
  • Work with Security department to maintain facility upgrades to security systems
  • Power of Attorney to sign DEA 222 form, responsible for completing, maintaining, and tracking all DEA 222 forms
  • Responsible for submitting CII quota applications to DEA; maintain organized DEA files on related activities
  • Coordinate and document DEA audits for sites and issue audit reports to management upon completion
  • Remain current on DEA regs in order to address organizational business needs

Requirements:

  • Bachelor's degree in a relevant field required
  • 2+ years' relevant work experience
  • Experience with IQVIA SOM software preferred

Skills and Abilities:

  • Ability to work with individuals in a professional manner up or down the organizational ladder
  • Proficiency in the following software applications: MS Office, Access Database, Excel, TrackWise, Acrobat Professional, and SAP
  • The ability to master new applications upon request
  • Strong work ethic, focused, able to prioritize workload with minimal supervision, detail-oriented, organization skills, able to multi-task and follow-up on open tasks; importantly, ability to execute on job functions in timely manner
  • Professionalism - Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of status or position; accepts responsibility for own actions; follows through on commitments
  • Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality
  • Adaptability - Adapts to changes in work environment; manages competing demands; changes approach or method to best fit situation; able to deal with frequent change, delays, or unexpected events
  • Initiative - Volunteers readily; Undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings
  • Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information

Physical Requirements:

  • Ability to sit/stand in an office environment

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