Regulatory Specialist

  • location: Rockland, MA
  • type: Contract
  • salary: $22 - $25.46 per hour
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job description

Regulatory Specialist

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Rockland, Massachusetts
job type: Contract
salary: $22.00 - 25.46 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Updating the product labeling
  • Overseeing product compliance registrations as per FDA regulations
  • Communicating with the pack site, manufacturing and other stakeholders as needed for label changes.
  • Updating dailymed, company website and other systems as needed with FDA approval labels
  • Internal communications for OPDP alignment
  • Support eCTD AdPromo submissions
  • Closely work external vendors to generate product and establishment registration (SPLs)
  • Help to perform QC activities of labeling or RA submissions
  • Help to prepare periodic reports submissions such as Annual reports
 
qualifications:
  • BS, Scientific discipline
  • Exposure to XML/SPL
  • 1-3 Years' experience in US Regulatory Affairs for both drugs and devices
  • Demonstrated knowledge of FDA regulations
  • Careful attention to detail managing document tracking, version control and file conversion (MS Word & Adobe)
 
skills: FDA, MS-WORD, CTD Structure, Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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