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SR. Director GRA CMC Biologics

Framingham, MA
Job Order: GD-711

Job Descriptions:

  • Leads and manages an RA CMC Team
  • Supports Global RA objectives
  • Supports the Vice President and Head of Global RA CMC Biologics
  • Contributes to global strategy and planning decisions
  • Manages team and develops staff

Directs RA CMC teams and provides senior strategic leadership in the following areas:

  • New applications for drugs/devices                                  
  • Plan/Prep/Submit/Review support
  • CTA / IND preparation and maintenance
  • BLAs
  • NDAs
  • License Maintenance                                             
  • Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals)
  • Site renewals (ex. Japan Accreditation)
  • Post-Marketing Commitments (PMCs) and Other Regulatory Commitments (ex. Stability data, from CTD text)
  • Assemble Information, including assigned deliverables
  • Direct frequent face to face meeting with global health authorities
  • Initial Communication to Responsible Parties and Stakeholders
  • Compile monthly summary update of PMCs and other regulatory commitments related to Sites for CQO
  • Track Internal Progress and assemble final package
  • Submit to Agency/Health Authority/Affiliate
  • Update data management systems
  • Issue Follow-up Communications to Responsible Parties and Stakeholders as necessary
  • Track Agency/Health Authority Progress
  • Close out Commitment in IRiS when Agency/Health Authority Indicates it has been Fulfilled
  • Communicate Close Out of Commitment to All Parties
  • Point of contact with Global Reg Affairs Product Leads
  • Interaction/liaise with FDA, Health Canada, ANVISA, PMDA and many others on  product topics
  • Post Approval Supplements                                
  • Regulatory strategy development
  • Preparing / Authoring Submissions – US
  • Preparing / Authoring Submissions – ROW
  • Review of submissions
  • Technical Review of site supporting documents (CoA, declarations, SMF, MBR,SOPs)
  • Notify Reg Ops for publishing and dispatch to BoH
  • BoH Response to Query – US
  • BoH Response to Query – EU
  • BoH Response to Query – ROW
  • Change Controls                                                   
  • Change control assessments – LCR in site system (TW)
  • If change affects multiple products, discuss and agree on global requirements

 

Job Requirements: 

  • Advanced degree (PhD preferred) with 10-15 years’ experience preferred
  • Expert knowledge of EMA and FDA regulations is essential.
  • Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
  • Excellent organizational and communication (written and verbal) skills.
  • Demonstrated ability to work successfully on project teams.
  • RAC certification preferred.
  • Previous experience working in a fast paced very high pressure environment on multiple product   lines
  • Manufacturing, QA/QC experience a plus

 

 

DATE POSTED 2019-09-25

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