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 Regulatory Affairs CMC Manager (JP7216)

Boston, MA · Biotech/Pharmaceutical
Job Title:  Regulatory Affairs CMC Manager (JP7216)
Location: Boston, MA or Thousand Oaks, Ca. Remote work during Covid-19 restrictions.
Employment Type:  Contract
Business Unit:  Regulatory Affairs - CMC Function
Duration: Initial 8 months with likely extensions
Job posting date: 4/23/20
3 Key Consulting is hiring a Regulatory Affairs Senior Associate for a consulting engagement with our client, a leading global biopharmaceutical company.
Ideal candidate: Previous experience with our client in the biotech industry, CMC, System/Programming knowledge. IT experience/programming experience in context of CMC/Module 3 a plus

Job Description:
Assist in the development of module 3 templates that will enable population by automation tools, and enable structured content management. Knowledge of the Common Technical Document (CTD), such as Module 3 for regulatory documents such as CMC related sections. Must have some knowledge of CMC and structured content. Be prepared to work within data systems and processes related to regulatory submissions. Working with cross collaborative teams and CMC authoring.

Why is the Position Open?
Supplement additional workload.
Top Must-Have Skill Sets:
  • 6+ years of regulatory experience
  • Common Technical Document (CTD) knowledge such as Molule 3 (CMC)
  • Data systems and processes related to regulatory submissions
Day to Day Responsibilities:
Work with a team to update module 3 templates to enable automation.  

Employee Value Proposition:
Ability to work cross functionally on a top priority team
Red Flags: No RA experience 
Interview process:
Phone screening followed by skype.
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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