Posted to MedZilla on 4/29/2017


Takeda Pharmaceuticals

US-MA, Associate Director, Global Regulatory Affairs, CMC 1700570-MZ


 
 

OBJECTIVES:
  • Participates in the development of regulatory CMC development and registration strategies as the RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams for assigned products throughout clinical development and commercial lifecycle. Ensures global strategies are successfully executed across both new product development and existing portfolio life cycle management.
  • Interfaces cross-functionally both within the regulatory affairs team as well as with commercial, clinical development, global marketing, quality, etc to ensure that data are identified, obtained and effectively presented for the registration of products world-wide.
  • Demonstrates leadership and comprehensive 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
  • Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
  • Provides CMC regulatory expertise for new business development/due diligence activities

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
  • Member of global project teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Recommends direction for key operations and new initiatives in collaboration with local and global stakeholders.
  • Leads, 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. Participates in agency meetings and may facilitate, depending on experience.
  • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment 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
  • 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
  • Leads and/or supports new business process development activities
  • 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
  • 8 + years pharmaceutical Regulatory CMC experience. Alternatively 5+ years pharmaceutical Regulatory CMC experience combined with 3+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Pharmaceutical Sciences, 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
  • Experience with global regulatory aspects of CMC involving undefined frameworks with medium technical complexity and defined scope.
  • Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
  • Demonstrated track record for successful interactions with FDA and preferably other global health authorities related to CMC submissions.
  • Demonstrated ability to work well within a matrix structure in a complex environment.
  • 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 preferred

LICENSES/CERTIFICATIONS:

  • RAC certification desirable but not mandatory
PHYSICAL DEMANDS:
  • Routine demands of an office based environment.
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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