Regulatory Affairs Senior Associate
The Judge Group Inc.

Location: REMOTE
Salary: $30.00 USD Hourly - $46.00 USD Hourly
Description: Our client is currently seeking a Regulatory Affairs Senior Associate
Our team is looking for a candidate who is able to work standard hours (ex. 7a-4p or 8am-5p etc.), with EST time zone preferred. The candidate would need to have flexibility to shift their hours to start and end their day at a later time, if additional support is needed for the PST time zone.

This job will have the following responsibilities:

• Must be able to speak to technical expertise-SharePoint working experience, excel and Smartsheet, Veeva vault hands on working experience (This is more important than a strong level experience with regulatory experience but should still have a few years of regulatory experience (i.e 1-2 yrs)
  
  Interpersonal communications skills
  
  Multitasker - able to juggle multiple priorities - ability to work independently
  

Qualifications & Requirements:

• • Maintain Regulatory document management and tracking systems
  • Support Activities for Clinical Trial and Marketing Application submissions/Health Authority correspondence
  • Data Management Point of contact between Regulatory Representatives/CMC, publishing teams and vendor
  • Support activities to manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions
  • Ensuring Regulatory compliance with SOPs and Regulatory authorities
  • Provide training, mentoring and support to Data Management team members and other functional areas, including vendors
  • Collaboration with external partners/outsourced CROs

Contact: asheikh@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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