Job Description

Regulatory Strategist
Job Number: 19-02419
 

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Regulatory Strategist for our client in Madison, NJ
 
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 

Responsibilities:
  • Provide support to the Marketed Product Portfolio support team as required
  • Manage and maintain internal and external databases and metrics as required
  • Manage post-approval changes (lifecycle and maintenance) for products manufactured at facilities and contract manufacturers
  • Prepare/author/manage regulatory sections for labelling supplements, annual reports and post-approval maintenance submissions
  • Submission preparation will be done within the document management system, templates and defined format support
  • Prepare regulatory sections for North America Annual Reports
  • Ensure that regulatory documents are prepared accurately, completely and on-time
 
Qualifications:
  • 1-2 years of experience
  • Basic computer skills
  • MS office, excel, word, outlook
  • Main focus is Lifecycle management, Annual reports
  • Experience with FDA database
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Maria Castañeda
maria.castaneda@eclaro.com
6463571235
Maria Castañeda | LinkedIn
 
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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