Posted to MedZilla on 4/28/2017


Takeda Pharmaceuticals

US-MA, Dir, Global Regulatory Affairs - CMC 1701008-MZ


 
 

OBJECTIVES:
  • Oversees the development and execution of regulatory CMC development and registration strategies as the 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.
  • Demonstrates advanced relationship management skills
  • Support new business development/due diligence activities
  • Proactively recognizes and contributes to enhancing business processes

ACCOUNTABILITIES:

  • 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
  • As a project team leader or member, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle.
  • Manages and develops staff, if required, including staff professional development and project oversight accountability
  • Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements
  • 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.
  • 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
  • Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
  • Leads and/or contributes to business process development and enhancement
  • Evaluates change proposals for regulatory impact and filing requirements
  • Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives
  • Evaluate new business development opportunities or participate on due diligence teams
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
  • Must have a minimum of 10+ years pharmaceutical Regulatory CMC experience. Alternatively, 7+ years pharmaceutical Regulatory CMC experience combined with 3+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance)
  • 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 judgment 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 preferred

LICENSES/CERTIFICATIONS:

  • RAC certification desirable but not mandatory
TRAVEL REQUIREMENTS:
  • Up to 30%

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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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Schedule


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