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Regulatory Affairs Associate United Kingdom, Pompton Lakes United States,  

Kyowa Kirin (company)

Posted on : 19 June 2017

Project Description

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 company 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. 


Bedminster United KingdomNJ United States United Kingdom

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