New to IMS? Register Now

Forgot Your Password?

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

Shown below are the latest jobs from this category.

Human Resource Manager

Little Falls, NJ
Job Order: GD-715
       Job Descriptions: In charge of employee relations which includes leading the social and recreation committee, organizing lunches, staff outings and year end parties. Develop other employee relation activities and enhancements. Be the point of contact for any staff related employee relation issues. Conduct “check-in” discussion with new employees...
DATE POSTED 2020-01-23

HR Manager

Attleboro, MA
Job Order: GD-720
Job Descriptions: Serve as a business partner with the on-site management team to effectively manage the Human Resources function while maintaining compliance with industry regulatory agencies and company programs  Administer Staffing, Training, Employee Relations, Safety, Compliance, Benefits, Employee Retention, and Compensation programs at the local level and implement corporate-wide,...
DATE POSTED 2020-01-08

Territory Manager

London, Ontario
Job Order: CT-722
  Job Descriptions: Achieves territory sales objectives in all categories, including new product launches and increasing sales within the assigned territory. Maintains high retention rate of customer base through delivery of outstanding service and through effective analysis of the business needs of the customer. Develops a Monthly Business/Action Plan that supports the needs of their...
DATE POSTED 2019-11-05

Director Global Regulatory Affairs

Cambridge, MA and Bridgewater NJ
Job Order: GD-725
Job Description: Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for rare disease indications which adhere to US regulatory and company guidelines. Represent the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and...
DATE POSTED 2019-12-26

Area Sales Manager

Central Florida, San Francisco, New Orleans,Arkansas
Job Order: GD-726
Job Description: Drive the success and growth of your sales region by generating leads vigorously and effectively. Meet with prospective and existing customers to provide product demonstrations and close on all product confidently. Cultivate early customer relationships for all company products. Participate in 3-5 weekly phone calls with Regional Sales Manager, RSM, (call objectives clearly...
DATE POSTED 2019-11-18

Project Manager

Job Order: GD-727
Job Description: Proven ability to build strong relationship with internal customers, external customers, leasing agents, property managers, landlords, government agencies, and other stakeholders Excellent written and oral communication skills; ability to communicate appropriately with a variety of stakeholders Excellent organizational skills; ability to work under pressure, prioritize, manage...
DATE POSTED 2019-11-18

Please, enter a valid value

Thank you.

Your password successfully changed.