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Regulatory Affairs Senior Associate (JP7834)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Regulatory Affairs Senior Associate (JP7834)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  RA CMC Regions & Sites
Duration: 12 months with likely extensions
Posting Date: 10/21/2020
Note: Remote until COVID-19 restrictions are lifted.
3Key Consulting Inc. is hiring a Regulatory Affairs Senior Associate for a contract engagement with our client, a leading global biopharmaceutical company.

Job Description:
Responsible for preparation of the CMC documentation required for new Clinical Trial Applications and Marketing Applications. Position requires knowledge of the CTD format and content related to CMC, and related experience within the Pharmaceutical industry. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision and reports to manager.
Skills: experience in Regulatory Affairs or Quality Assurance in a regulated industry, with a focus on CMC matters.
Top Must-Have Skill Sets:
  1. 1-2 years work experience in Regulatory Affairs or Quality Assurance. CMC experience preferred.
  2. Work experience related to biotech or small molecule product.
  3. Knowledge or work experience related to CTAs, INDs, Marketing Applications and ICH CTD structure and format
Day to Day Responsibilities:
Preparation of CMC documentation to support new Clinical Trial Applications and Marketing Applications
Employee Value Proposition:
Opportunity to join a fast-paced team and exposure to multiple departments
Red Flags:
No prior work experience in pharmaceutical industry. Not able to be located in Thousand Oaks 5 days per week.
Interview process:
Phone followed by in-person interview
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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