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Job Details

Regulatory Affairs Associate

Company: Kyowa Kirin International plc
Location: Bedminster, NJ United States
Reference: 1WOFQA1
Closing Date: 21 Oct 17
Type: Full Time
Salary (£): Competitive

Job Summary:

Provide support for Post-marketing/Commercial Regulatory Affairs activities in the US.


Regulatory Affairs Associate

Provide support for Post-marketing/Commercial Regulatory Affairs activities in the US.

Key Responsibilities:

  • Post-marketing submissions:
  • Properly file and log all post-marketing submissions.
  • NDA Annual Reports:
  • Identify and communicate due dates to contributors
  • Collect contributions for, compose and assemble, and format the report
  • Work with Regulatory Operations (RO) to publish and submit the report via eCTD
  • Periodic Safety Update Reports (PSURs)
  • Identify and communicate due dates to contributors
  • Prepare cover letter and 356h Form
  • Chemistry, Manufacturing, and Control submissions
  • Other post-marketing submissions as determined by Director of Commercial Regulatory Affair


  • Responsible for entering packaging revisions (directing packaging revisions) into the Kyowa Kirin packaging management system as instructed by the Director of Commercial Regulatory Affairs
  • Proofread all revised packaging for accuracy


  • Proofread US Prescribing Information, Patient Information, Medication Guides, and Instructions for Use as required
  • Send US labels to vendor for conversion to .XML or SPL files as needed or instructed prior to FDA submission
  • Assist in formatting USPIs, when needed
  • Assist in maintaining USPI files

Legal, Medical, and Regulatory Committee (LMR)

  • Work with Legal, Medical (ie, Medical Affairs/Local Safety Officer/Pharmacovigilance), and Regulatory reviewers and with Marketing staff and outside vendors (advertising agencies)
  • Function as LMR coordinator for both Promotional and Medical Review pieces
  • Run LMR meetings (eg, start teleconferences, share documents)
  • Incumbent may be required to work within an electronic document management system, such as Veeva Vault
  • Maintain files of all pieces reviewe
  • Review the communications (pieces) post-LMR
  • Collect 2253 approval (signature) from Director Commercial Regulatory Affairs
  • Maintain Regulatory files
  • Other Regulatory duties as determined by Director of Commercial Regulatory Affairs.

Position Requirements

  • Candidates must have completed a 4-year college degree, preferably a Bachelor of Science in the life sciences, or advanced degree (eg, M.S. or PharmD).
  • Minimum of 2-6 years of work experience in the pharmaceutical industry.
  • An eye for detail is essential for this position and will especially be needed when reviewing materials post-LMR, and when proofreading packaging and labeling (especially Prescribing Information).
  • Excellent communications skills, both verbal and written, are essential for this position and strongly needed across all responsibilities.
  • The incumbent must be able to effectively manage competing responsibilities and due dates.
  • Experience working within the Veeva Vault system is highly desirable.

Physical Requirements:

  •  1-2 weeks possible global travel a year

Key Competencies

The desirable candidate will be completely reliable; demonstrate a good professional attitude; work well with others; be hard working, quiet, and focused; and have a desire to learn and develop their career in Regulatory Affairs in the areas of advertising and promotion, labeling, and Post-marketing or Commercial Regulatory Affairs.

Apply for this job: Regulatory Affairs Associate

Contact Information:

Address:  Kyowa Kirin Inc
135 Route 202/206 Suite 6 Bedminster NJ 07921


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