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
