Posted to MedZilla on 8/17/2019


Takeda Pharmaceuticals

US-MA, Senior Director, Global Regulatory Affairs CMC - Marketed Products R0009103-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 Director, Global Regulatory Affairs CMC - Marketed Products in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Global Regulatory Affairs CMC team, you will be empowered to ensure products are manufactured or distributed to meet required legislation, and a typical day will include:

OBJECTIVES:

  • Leads the development and implementation of CMC regulatory strategies for products throughout the development and commercial lifecycle.
  • Globally influences and is generally considered a key opinion leader and resource within Takeda and externally.
  • Influences changing regulations and guidance, interfaces with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend regulatory CMC strategy.

ACCOUNTABILITIES:

  • Responsible for demonstrating Takeda leadership behaviors.
  • Develops global Regulatory CMC strategies and updates based on regulatory and business changes.
  • Acts as CMC regulatory expert for global project teams/task forces and is accountable for recommending global CMC regulatory strategy.
  • Builds and manages relationships through active partnering with key internal and external stakeholders.
  • Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for CMC.
  • Act as the CMC Regulatory representative on Core Team and Adjudication Committee for all CMC RA Compliance initiatives as well as governing committees on GMS initiatives.
  • Provides leadership of global GRA CMC strategists plus manage global temporary resources to both set strategy and execute against the various strategy. Reviews, evaluates and approves CMC strategies associated with all initiatives.
  • Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions (e.g. Emerging Markets RA) to ensure effective strategies are developed and project execution is on target.
  • Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for CMC.
  • Represents as required the regulatory function in the evaluation of new product opportunities internally and externally.
  • Manages a budget for external resource needs for all initiatives.
  • Leads or plays a key role on internal Takeda governance committees
  • Demonstrated track record for successful interactions with FDA and other global health authorities related to CMC submissions.
  • Relationship management and constructive partnering with international Health Authorities (such as FDA, EMA, etc.)
  • Significant staff management experience is required. Experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with international regulatory authorities is also required.
  • Provides leadership of global GRA CMC business units consisting of geographically dispersed RA CMC professionals, including staff management and development.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • 15+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, with international experience strongly preferred.
  • Proven ability to liaise with Regulatory Agencies, having served as lead in Agency Interactions and product development meetings, international experience preferred.
  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
  • Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
  • Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
  • Demonstrates leadership, problem-solving ability, flexibility and teamwork
  • Exercises good judgement in elevating and communicating actual or potential issues to line management.
  • Excellent written and oral communication skills required.
  • Active participation in Agency/Industry groups/forums expected.

LICENSES/CERTIFICATIONS:

  • None required.

PHYSICAL DEMANDS:

  • Routine demands of an office based environment.
  • 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 10-30% travel.

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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