Regulatory Affairs Specialist

Attention to detail, Audit, Business continuity, Communication skills, Compliance, Computer, Documentation, Education, FDA, IMPACT, Microsoft Windows, Pharmaceutics, QA, Technical writing, Time management, RA Associate, Regulatory affairs associate, pharmaceutical, PHARMA
Full Time
$80,000 - $90,000
Travel required to 10%.

Job Description

MUST HAVE PHARMACEUTICAL EXPERIENCE

ROLE AND RESPONSIBILITIES

  • Prepare, review and maintain compliance and regulatory documents to ensure accuracy, quality, and integrity
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, and comprehensiveness, work with submissions management vendor to maintain submissions
  • Maintain files and retrieve requested documents during inspections, audits, traceability exercises, recalls, business continuity, etc
  • Provide responses to regulatory agencies regarding product information, audits, or issues • Evaluate applicable laws and regulations to determine impact on company activities and processes
  • Perform other duties as assigned

QUALIFICATIONS AND EDUCATION REQUIREMENTS

  • 3+ years’ experience in technical writing
  • Experience in pharmaceutical regulatory roles
  • Experience with the following regulations: FDA, GMPs, CFRs • Strong attention to detail
  • Advanced written and verbal communication skills
  • Time management and prioritization skills
  • Ability to work well with various departments in the company

PREFERRED SKILLS

  • Good verbal and written communication skills
  • Computer skills (Microsoft Windows and Office programs),
  • Certification in a regulatory discipline preferred

Posted By

Chris Cochran

11364 Perry Highway Wexford, PA, 15090

Contact
Dice Id : 90995475
Position Id : 6549197
Originally Posted : 2 months ago
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