Job Title: Regulatory Affairs Senior Associate
Location: Remote (EST time zone preferred)
Job Summary:
- We are seeking a dynamic and tech-savvy Senior Associate for our Regulatory Affairs team. This 100% remote role requires a candidate who can work standard hours with flexibility to adjust their schedule as needed. The ideal candidate will be comfortable learning new systems, managing content in SharePoint, and have a knack for process mapping and project management.
Job Responsibilities:
- Maintain Regulatory document management and tracking systems
- Support activities for Clinical Trial and Marketing Application submissions/Health Authority correspondence
- Act as a Data Management Point of contact between Regulatory Representatives/CMC, publishing teams, and vendors
- Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions
- Ensure Regulatory compliance with SOPs and Regulatory authorities
- Provide training, mentoring, and support to Data Management team members and other functional areas, including vendors
Skills Required:
- Proficiency in SharePoint, Excel, and Smartsheet
- Hands-on experience with Veeva Vault
- Strong interpersonal communication skills
- Ability to multitask and work independently
- Experience working with stakeholders
- Regulatory affairs knowledge and experience (1-2 years)
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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