Posted to MedZilla on 8/18/2019


Takeda Pharmaceuticals

US-MA, Director, Global Regulatory Affairs CMC - Cell and Gene Therapy R0009113-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 Director, Global Regulatory Affairs CMC - Cell and Gene Therapy in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director working on the Global Regulatory Affairs CMC team, you will oversee the development and execution of regulatory CMC development and registration strategies, and a typical day will include:

OBJECTIVES:

  • RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.
  • Demonstrates high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization.
  • Manages and/or mentors staff members, if required.
  • Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
  • Provides regulatory CMC expertise for new business development/due diligence activities.
  • Proactively recognizes and contributes to enhancing business processes.

ACCOUNTABILITIES:

  • Responsible for demonstrating Takeda leadership behaviors.
  • Independently plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
  • Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization.
  • Lead team members that defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.
  • Leads and/or contributes to business process development and enhancement
  • Evaluate new business development opportunities or participate on due diligence teams.
  • Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.
  • Responsible for ensuring that project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
  • Exercises good judgement in elevating and communicating actual or potential issues to line management.
  • Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
  • Represents Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
  • Interacts directly with international Health Authorities, as required.
  • Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.
  • Manages and develops staff, if required, including staff professional development and project oversight accountability.
  • Evaluates change proposals for regulatory impact and filing requirements.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, 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.
  • Proven US regulatory experience in the area of cell and gene therapy a must. Global experience is considered a plus.

  • 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, including overnight trips.
  • Requires approximately up to 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

 
 


* 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.