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.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
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
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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 takedajobs.com.
No Phone Calls or Recruiters Please.