Posted to MedZilla on 10/13/2019


Takeda Pharmaceuticals

US-MA, Senior Associate, Global Regulatory Affairs CMC - Submission Management R0011613-MZ


 
 

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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 Associate, Global Regulatory Affairs CMC - Submission Management in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Associate working on the Submission Management team, you will be empowered to support the Global Regulatory CMC Lead in preparation of development submissions (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Post-Approval Changes, and a typical day will include:

OBJECTIVE:

  • With supervision, supports the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products. Supports Regulatory teams for assigned products throughout clinical development and commercial lifecycle.
  • Develops a solid understanding of global RA CMC regulations and guidelines, and participates in the development of strategies to enhance probability of regulatory success or enhancing regulatory compliance.
  • Interacts and effectively communicates with other internal and external colleagues.

ACCOUNTABILITIES:

  • With supervision, executes regulatory submissions for assigned projects.
  • Helps define CMC content (data and documentation) requirements for regulatory submissions.
  • With supervision, participates in Health Authority interactions and supports preparation activities for meetings with Health Authorities on CMC related matters.
  • Ensures line management is apprised of developments that may impact regulatory success, communicating in a professional and timely manner.
  • Evaluates change proposals for global regulatory impact with supervision and may support planning of variations and amendments.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education and Experience Required:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • 2 yrs work experience in a supportive role; experience with pharmaceuticals or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) is valuable.
  • Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents) is valuable
  • Demonstrates attention to detail and problem-solving abilities.
  • Excellent written and oral communication skills required.
  • Experience working with cross-functional teams (or an equivalent), preparation of high quality documents (i.e., for submissions), and an ability to execute on activities

PHYSICAL DEMANDS:

  • Routine demands of an office based environment.
  • Manual dexterity required to operate office equipment (ie computers, phones, etc)

TRAVEL REQUIREMENTS:

  • Ability to attend offsite meetings that may involve overnight stay

WHAT TAKEDA CAN OFFER YOU:

  • 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 takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-LC1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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