Posted to MedZilla on 4/29/2017


Takeda Pharmaceuticals

US-MA, Senior Associate Global Regulatory Affairs Development CNS 1700718-MZ


 
 

OBJECTIVES:
  • Executes regulatory activities for team members or projects in accordance with applicable regulations and guidelines, and in line with the overall global regulatory strategy.
  • Supports Global Regulatory Leader or Regional Regulatory Lead on individual project(s), including submissions, preparation for agency interactions and regulatory research related to project(s).
  • Focused on non-clinical and clinical aspects of drug development and associated regulations.

ACCOUNTABILITIES:

  • Works with cross-functional teams to communicate submission requirements, obtain and review technical information for the preparation of IND and NDA Annual Report, safety and information amendments for submission to FDA for proper positioning, context and completeness.
  • Ensures all data for submission are complete and in compliance with company guidelines and FDA regulatory requirements.
  • Responsible for achieving routine submissions (e.g. IND amendments).
  • Responsible for researching and assisting in the preparation of general responses (formulating and/or editing) for clinical and non-clinical data from FDA.
  • Provides regulatory review of clinical trial documents (protocols, reports, etc,) as identified by applicable SOPs for submission to FDA.
  • Attends study team meetings and provides regulatory guidance on regulatory administrative and logistical issues.
  • Assists with agency meetings.
  • Executes global regulatory strategies.
  • Supports individual projects.
  • Works well in a matrix environment and can manage multiple priorities. Works well with others.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Works with cross-functional teams to communicate submission requirements, obtain and review technical information for the preparation of IND and NDA Annual Report, safety and information amendments for submission to FDA for proper positioning, context and completeness.
  • Ensures all data for submission are complete and in compliance with company guidelines and FDA regulatory requirements.
  • Responsible for achieving routine submissions (e.g. IND amendments).
  • Responsible for researching and assisting in the preparation of general responses (formulating and/or editing) for clinical and non-clinical data from FDA.
  • Provides regulatory review of clinical trial documents (protocols, reports, etc,) as identified by applicable SOPs for submission to FDA.
  • Attends study team meetings and provides regulatory guidance on regulatory administrative and logistical issues.
  • Assists with agency meetings.
  • Executes global regulatory strategies.
  • Supports individual projects.
  • Works well in a matrix environment and can manage multiple priorities. Works well with others.

PHYSICAL DEMANDS:

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Carrying, handling and reaching for objects.
  • Ability to sit or stand for long periods of time while traveling.
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Requires approximately 20 % travel.



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