Posted to MedZilla on 4/21/2018

Takeda Pharmaceuticals

US-MA, Senior Submissions Specialist - Commercial Submission Management R0000464-MZ


By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use.

Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Submissions Specialist - Commercial Submission Management in our Boston, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Submissions Specialist - Commercial Submission Management working on the Technical Operations team, you will be empowered and a typical day will include:

  • Executes commercial submission activities for cross-functional team members in accordance with applicable regulations and guidelines, and in line with global quality compliance

  • Independently interfaces with internal and external colleagues as well as CMOs and alliance partners to obtain CMC documentation required for initial marketing authorizations, renewals of marketing authorizations, post-approval variations/submissions, GMP registrations and renewals

  • Responsible for the approval of regulatory documentation to support global regulatory dossiers

  • Provides support to cross-functional team members as required for commercial submission activities


  • Independently plans, executes and manages the approval of CMC eCTD sections for regulatory submissions for assigned compounds in global marketing applications and post-approval life cycle activities

  • Serves as a liaison to Contract Manufacturing Organizations (CMO) to obtain supporting CMC documentation required for regulatory submissions

  • As a CSM team leader, ensures project team colleagues, line management and key stakeholders are apprised of developments that may impact regulatory submission timelines, exercising good judgment and communicating in a professional and timely manner

  • Attend Change Control meetings to be informed of upcoming regulatory submissions in which colleagues from GMS and/or GQ will be required to author

  • Collaborate with Quality Compliance to provide any CMC documentation required for inspections of CMOs and alliance partners

  • Independently manages Rapid Response Team consisting of GMS, GQ and RA in providing approved responses to health authority queries in the timeframe required

  • Identify issues that may delay approval or delivery of regulatory documentation and recommend appropriate action

  • Works well in a matrix environment and can manage multiple priorities.


  • BS/BA degree and at 1- 3 years of pharmaceutical industry experience.

  • Preferred experience in a related aspect of commercial drug manufacturing

  • Demonstrates strong skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

  • Works well with others


  • None


  • None


  • Minimal (0 to 10% domestic and / or international)


  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement

  • Company match of charitable contributions

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs

Empowering Our People to Shine

Learn more at

No Phone Calls or Recruiters Please.


Cambridge, MA

Worker Type


Worker Sub-Type


Time Type

Full time

Please visit our website at


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.