Regulatory Affairs Senior Associate

Thousand Oaks, California

Job Title: Regulatory Affairs Senior Associate

Location: Thousand Oaks, CA (Remote)

Pay Rate: $37/hr – $39/hr
  
Responsibilities:  

  • Coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Management and execution of the preparation, delivery, and electronic archiving of documentation for inclusion in regulatory submissions.
  • Coordination and execution of regulatory affairs processes and deliverables.
  • Works under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of regulatory documents.

 
Required Skills:  

  • Previous Regulatory Experience.
  • Knowledge of FDA.
  • Degree in life sciences.
  • Good communication skills – both oral and written.
  • Ability to understand and communicate scientific/clinical information, Organizational skills.
  • Knowledge of regulatory submissions including IND, sIND, BLA, and sBLA useful. The use of document archival systems/electronic document repositories is also useful.
  • Proficiency in Microsoft Suite (Outlook, Word, Excel, PowerPoint) Technical competency for data entry into electronic document management systems, SharePoint sites and other databases/trackers.

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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