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CMC Regulatory Affairs Senior Manager (JP9443)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  CMC Regulatory Affairs Senior Manager (JP9443)
Location: Thousand Oaks, CA. (Remote can be considered)
Employment Type:  Contract
Business Unit: 
RA CMC Regions & Sites
Duration: 6 months with likely extensions
Posting Date: 11/11/2021

Note: Core working hours: 8:30AM-2:30PM PST as core hours with flexibility on either side to work an 8 hr day
3 Key Consulting is hiring a CMC Regulatory Affairs Senior Manager for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:

This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
  • Responsible for the strategy and execution of the site-specific aspects of the preparation of
    CMC post-market supplements and facility registrations.
  • Interfaces with site functions to coordinate preparation of regulatory filings, identification
    of issues and factors that may implicate a regulatory strategy or activity.
  • Coordinate site-specific change control regulatory assessments with input from the CMC Product
    teams and the CMC Region representative.
  • Liaise with other Functions in development, operations, and commercial to ensure alignment of
    global regulatory strategies, timing, execution and plans

Core Responsibilities:
  • Change control assessments for raw materials, components, specifications, etc.
  • Develop regulatory strategies and author submissions related to raw material and component shortages

Why is the Position Open?
Supplement additional workload on team
Top Must-Have Skill Sets:
  • Must have direct CMC experience (RA CMC, Manufacturing, Quality Control, etc.).
  • Must be able to work independently and multi-task in a fast paced environment.
  • Experience working on biologics and small molecules, commercial and clinical is highly desired.
  • Min 5 years of experience in this position

Day to Day Responsibilities:

Successful candidate will primarily be supporting regulatory reporting of raw material and component changes as a result of COVID-related industry wide shortages. This will include evaluating data packages, developing global filing strategies and potential communication with health authorities
Employee Value Proposition:

The person in this role will provide assistance to the team in communicating company's need to provide.

Red Flags:
  • Verbose, unorganized, cluttered CV
  • No CMC or direct manufacturing of biological MAb experience
Interview process:

Video interviews.

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 take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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