Job Description

Regulatory Specialist
Job Number: 20-08542
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Regulatory Specialist for our client in Sanford, NC. 
 
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!
 
Position Overview:
  • For Regulatory Submission Strategy/Authoring, activities shall include, but not be exclusive to:
    • Prepare/author regulatory sections (e.g. QOS and Module 3) for clinical trial applications and amendments, registration dossiers, annual reports and post-approval variations and renewals.
    • Submission preparation will be done within the Client document management system, GRA templates and Client defined format; develop regulatory post-approval filing strategies and variations for global products; prepare regulatory sections for US Annual Reports; ensure that regulatory documents are prepared accurately, completely and on-time; Manage post-approval changes for products manufactured at Client facilities and contract manufacturers. 
    • Prepare responses to Health Authority queries and requests and liaise with Global Regulatory Team to progress the submission/project support as required.
    • Other activities may include: process and track CMC documents in the change management system and manage database, project management activities, general administrative duties as needed.
 
Qualifications:
  • Regulatory exp. is a must with a Highly preferred background in vaccines
  • Documentation mgt, query responses, assist with trackers and spreadsheets, assist with annual reports.
  • Computer savvy, team player, comfortable speaking up and asking questions, comfortable working remote, go-getter
  • PM skills= helpful
  • BS degree or higher
 
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:
John Bayog
John.Bayog@eclaro.com
6466952925
John Bayog | 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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