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Regulatory Compliance Assistant
Ref No.: 18-01198
Location: Fort Worth, Texas
Start Date / End Date: 04/01/2018 to 10/01/2018
Department: 160613 : 160613
Sandoz Inc.
Job Category: Professional - Miscellaneous
Job Code:
Job Title: Regulatory Compliance Assistant
Keywords:
Number of Positions: 1
Remaining Positions: 1
Duties:
    • Prepares and submits regulatory filing documents.

    • Monitors and tracks information and requirement changes.

    • Some interaction with regulatory agencies.

    • Compiles and reviews ANDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions.

    • Reviews ANDA labeling documents.

    • Maintains Regulatory Databases

Skills:

Good technical writing skills, computer knowledge, some working knowledge of regulatory and drug product development process

Education:

Bachelor's Degree in a scientific-related field. 3 years of pharmaceutical industry experience.

Languages:
English Read Write Speak
Attachments:
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Skills:

Required

  • PRODUCT DEVELOPMENT
  • REGULATORY COMPLIANCE
  • ANDA
  • DATABASES
  • FDA

Additional

  • FILING
  • TRANSMISSIONS
  • WRITING SKILLS
Languages: English( Speak, Read, Write )
Minimum Degree Required:
Also Preferred:
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Work Performed
Onsite:
State/Province: Texas
City/Town: Fort Worth
Address: 6201 South Freeway
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Start Date: 04/01/2018 Hours Per Week: 40.00
Est. End Date: 10/01/2018 Hours Per Day: 8.00
Schedule Notes: Days Per Week: 5.00

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