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Regulatory Affairs Manager-Asia Pacific Lead (JP7741)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Regulatory Affairs Manager-Asia Pacific Lead (JP7741)
Location: Thousand Oaks CA
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 1 October 2020
Note: Remote until COVID-19 restrictions are lifted.
 
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:
  • 2-3 years Regulatory Affairs CMC experience. CMC-specific regulatory knowledge & experience.
  • Previous work experience in the Pharmaceutical/Biotech industry.
  • Ideal candidate would have RA experience within JAPAC region.
 
Job Details:
  • This is an opportunity for a Manager position in client's Regional Regulatory Affairs, CMC group.
  • This group's purpose is to facilitate product development and global registration by developing and executing Regulatory CMC strategies for the client products throughout the product lifecycle.
  • The RA CMC Asia Pacific lead is responsible for the planning, management, coordination, and execution of regulatory submissions for products within the JAPAC Regional portfolio according to the approved filing plan in compliance with corporate standards, and local regulatory requirements.
  • The RA CMC Asia Pacific Lead is the primary point of contact and interface with the Regional Regulatory Lead (RRL) and Local Regional Representative (LRR) for specific CMC strategy and CMC activities that impact product development within the region.
  • The RA CMC Asia Pacific lead will support the RA CMC Global teams for the preparation of Clinical Trial applications (CTA), Marketing Applications (MA), and Post-Approval changes.

    Additional responsibilities of the RA CMC Asia Pacific Lead include:
  • Contribute to the development of the Global Regulatory CMC strategy and execute the preparation of CMC components for CTAs and MAs, and LCM submissions for client products within JAPAC.
  • Assess proposed manufacturing and quality changes for regional reporting requirements, and manage subsequent post approval variation submissions across the region.
  • Coordinate and manage responses to Health Authority requests for information related to CMC matters.
  • Document Archiving: Ensure appropriate compliance with archiving/tracking and monitor metrics from tracking systems.
  • Conduct contingency regulatory planning/risk assessment for product development plans and support regulatory interaction strategies.
 
Top Must have Skill Sets:
  • 2-3 years Regulatory Affairs CMC experience. CMC-specific regulatory knowledge & experience.
  • Previous work experience in the Pharmaceutical/Biotech industry.
  • Strong & effective oral and written communication skills; proven ability to communicate effectively with different management levels.
 
Employee Value Proposition:
Offers opportunity to be developed and exposed to multiple products within the pipelines
 
Red Flags:
1. No related Regulatory Affairs experience
2. No previous work experience in the Pharmaceutical/Biotech industry
3. Doesn't want medical device experience
 
Interview Process:
Phone Interviews: (1) Manager and (1-2) 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.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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