Sr Associate Regulatory Affairs (JP4137)

Location: Thousand Oaks, CA
Date Posted: 04-16-2018
Job Title: Sr Associate Regulatory Affairs (JP4137)
Location: Thousand Oaks, CA ( No remote workers )
Employment Type: Contract
Duration: 24 months with likely extensions
Business Unit: RA CMC Regions & Sites
 
‚Äč3Key Consulting is looking for a Sr Associate Regulatory Affairs for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA
 
JOB SUMMARY:
 
  • Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
  • Assists in developing procedures to ensure regulatory compliance.
  • Has knowledge of commonly-used concepts, practices, and procedures within a particular field.
  • Relies on instructions and pre-established guidelines to perform the functions of the job.
  • Works under immediate supervision.
  • Typically reports to a supervisor or manager.
 Skills: ; experience in a regulated industry, science academia or clinical practice 

TOP MUST-HAVE SKILL SETS:
1. 1-2 years of experience in regulatory affairs, or biotech industry experience
2. Experience in 1 or more of the following biotech industry areas: Regulatory, Quality Assurance, or Manufacturing
3. Excellent Communication skills
 
DAY-TO-DAY RESPONSIBILITIES: First 30 days include system onboarding and training. Also CW will be assigned a Project and expected to familiarize self with product/project background. Support Regulatory Managers in tasks related to performing product development and lifecycle management activities to support regulatory applications. Coordinate preparation of regulatory filing documents supporting new marketing applications and clinical trial application. Interfaces with Operations, various product teams, various site teams, regional teams and other contract services as directed.
 
RED FLAGS:
1) lack of biotech experience,
2) not meeting minimal education requirements,
3) not able to be located on-site 5 days a week,
4) lack of work experience.
 
INTERVIEW PROCESS:
1) Manager will phone screen applicants. 2.) Potential candidates will interview (phone or on-site interview) with other Amgen team members. Interviews to start ASAP
 
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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.**No Third-party Vendors Please**
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Regards,
 
3KC Talent Acquisition Team
 
 
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