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Sr Associate Regulatory Affairs (JP8301)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Sr Associate Regulatory Affairs (JP8301)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date:  3/5/2021
Note: Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Sr Associate Regulatory Affairs for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Pharma/Biotech experience required.
  • 1-2 years work experience in Regulatory Affairs or Quality Assurance. CMC experience preferred. (Pharma or Biotech)
  • Quality or regulatory background required.
  • Bachelors Degree (Scientific related degrees required)

    Job Details:
  • 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 has 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:
  • Degree in life sciences, biochemistry, or chemistry
  • Experience in biopharmaceutical or pharmaceutical industry
  • Familiarity with CTD structure
Day-To-Day Responsibilities:
Preparation of CMC documentation to support new Clinical Trial Applications and Marketing Applications.
Tasks may include creating and/or maintaining submission timelines and tables of contents.
Employee Value Proposition:
A person in this role will gain hands on experience to facilitate career development.
Red Flags:
  • No prior work experience in pharmaceutical industry.
  • Candidates with experience limited to academic setting course work.
  • Candidates with work experience limited to pharmaceutical devices.
Interview Process:
Candidates will be phone screened by Manager. Candidate may also be interviewed by other team members.
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 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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