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Regulatory Affairs Manager-CMC – REMOTE (JP7567)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Regulatory Affairs Manager CMC – REMOTE (JP7567)
Location: Virtual- REMOTE, must work in EST time zone.
Employment Type: Contract
Business Unit: CMC Devices and Biosimilars
Duration: 18 months with likely extensions
Job posting date: 17 August 2020
 
3 Key Consulting is hiring a Regulatory Affairs Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
  • This candidate will be fully remote & must work in EST time zone.
  • This is an individual contributor - managing a process.
  • Bachelor’s degree Minimum.
  • 5+ years of Regulatory experience: Manufacturing, Pharma, Chemistry, Engineering.
  • Must have knowledge of Chemistry Manufacturing/Controls regulatory and Lifecycle management of a commercial product.
  • Ideal candidate will have solid dosage product & FDA interaction with regulatory agencies.
     
Job Details:
The Regulatory Affairs Manager, CMC will lead registrations of Client's synthetics products and will be also the lead for life-cycle management (LCM) of commercial products, including determining regulatory reporting, and global filing strategies and requirements for post-approval variations related to synthetics (small molecule) products. The Manager will also facilitate communication of requirements and strategies to Product Delivery Team (PDT) in addition to the functional areas. The Manager will follow standard department and global marketing template processes to drive consistency across MAA submissions and post-approval programs.

Serve as Regulatory CMC voice for product teams by providing the following services:

• Define minimum regulatory filing requirements for post approval programs and or new MAA.
• Provide sound regulatory strategy through development of marketing application strategic plan and/or events.
• Global regulatory strategy.
• Development of post-approval variations including maintenance of applications.
• Maintain product compliance through appropriate regulatory filings and activities.
• Support Change Management activities.
• Manage regulatory agency questions, commitments and periodic reports.
• Facilitate agency interactions, including meeting preparation, meetings and briefing documents.
• Ensure alignment with variation master plans, develop global implementation requirements, and implement changes throughout product life-cycles.
• Liaise with regional regulatory CMC counterparts and other functions within development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plans.
• Contribute to the Product Delivery Teams Variation Master Plan.
• Maintain information for Center dashboards; and collaborate with other Centers to ensure information alignment.
• Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current.
• Participate as an active member of cross-functional teams including GRT, PDT, PQT, etc., as needed.

Top Must have Skill Sets:
  • Knowledge of Chemistry Manufacturing and Controls regulatory (CMC).
  • Knowledge of Lifecycle management of a commercial product.
  • Ability to work cross functionally in a fast-paced environment.
 
Employee Value Proposition:
Ability to explore new product development.
 
Red Flags:
Lack of experience, lack of degree, lack of top 3 must have skills.
 
Interview Process:
Phone screen & Video 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 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.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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