Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.
Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferred
Position type: 1 year contrat (through November 2025); extension possible.
Position Overview: As a Regulatory Affairs Senior Associate, you will manage regulatory document tracking systems, support clinical trial and marketing activities, and assist with regulatory application submissions and communications with health authorities, ensuring compliance with SOPs and regulatory standards. You’ll serve as the primary point of contact for data management between Regulatory, CMC representatives, publishing teams, and vendors. Key responsibilities include managing Protocol Amendment New Investigator (PANI) submissions, updating PI information, and providing training, mentoring, and support to Data Management team members and other functions, including vendors. Additionally, you’ll collaborate closely with external partners and outsourced CROs.
Essential Duties and Responsibilities:
- In order to support our team's ongoing projects, we are seeking a candidate who is comfortable with learning new systems, has experience managing content in SharePoint, has working experience with the Six Sigma methodology, process mapping and project management experience.
- Regulatory affairs knowledge will be considered.
- Any Regulatory certifications/qualifications will add value.
- Technical understanding of Regulatory systems will be desirable. Knowledge and interest in SQLs/Databases will also be considered.
Qualifications:
- Master's degree (MS) degree OR
- Bachelor's degree (BS) and two (2) years' experience OR
- Associate's degree (AS) and sic (6) years of experience OR
- High school diploma / GED and eight (8) years of experience
- Experience with SharePoint, Excel, Smartsheet, and Veeva Vault.
- Excellent communication skills and ability to work closely with stakeholders
- Ability to work independently and handle multiple prioritites
