Associate Regulatory Affairs-CMC

Thousand Oaks, California

Job Title: Associate Regulatory Affairs-CMC (Fully Remote)

Description:

  • We are seeking an entry-level Associate Regulatory Affairs-CMC to provide product support to our regulatory Chemistry, Manufacturing, and Controls (CMC) department across various regions and development phases.

Responsibilities:

  • Organize, manage, and execute regulatory CMC projects in support of regulatory submissions.
  • Format documents per style guide, search for and organize data from regulatory repository systems.
  • Draft meeting agendas and minutes, manage document reviews, and other tasks as requested.

Skills Required:

  • Degree in life sciences, biochemistry, or chemistry.
  • Desire to learn Regulatory Affairs CMC and global submission strategy.
  • Strong organizational skills with attention to detail.
  • Proficient time management skills and ability to prioritize workload.
  • Ability to work both independently and as a team member.
  • Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint, and Project.
  • Familiarity with eCTD structure is preferred
  • Motivated with initiative to learn quickly.

About SSi People: 
With over 25 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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