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Head, Nonclinical Regulatory Writing & Submissions

Cambridge, Massachusetts


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Head, Nonclinical Regulatory Writing & Submissions

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Job ID R0023406 Date posted 09/28/2020 Location Cambridge, Massachusetts

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Job Description


The Head of Nonclinical Regulatory Writing & Submissions (NRWS) will report directly to the Head of Takeda’s Preclinical and Translational Sciences (PTS) group. The PTS group also includes pharmacology, drug metabolism and pharmacokinetics (DMPK), drug safety research and evaluation (DSRE), quantitative translational sciences (QTS), comparative medicine and operational functions. This individual will be responsible and accountable for:

  • Leadership and management of the NRWS team as well as the planning, tracking, compilation and delivery of all nonclinical documents encompassing the Takeda R&D portfolio for internal development programs and Global regulatory submissions. This includes the management of all nonclinical documents generated by the PTS group, such as nonclinical study reports, summary documents, and all authored regulatory documentation supporting programs throughout the project’s lifecycle (pre-development through post-marketing).
  • NRWS representation on the PTS leadership team. Serve as a primary stakeholder, providing expertise and alignment with internal operating processes and Global Regulatory and cross-functional initiatives. The Head of NRWS develops and implements detailed plans for the compilation, QC, review, compliance approval and transfer to Regulatory Affairs of preclinical/translational and nonclinical generated documents for regulatory submissions across all global therapeutic area units (TAUs)/ drug development units (DDUs) and functional teams within PTS, including reports generated by contract research organizations.
  • Maintaining and supporting an engaged, goal-driven team and balancing strategic considerations with technical aspects in resolving regulatory submission issues.
  • Establishing and maintaining systems and procedures for training and maintaining quality standards for the format and content of nonclinical documents and is responsible for ensuring final submission-readiness and delivery of nonclinical documentation. The candidate will be a standing member in R&D IT initiatives that impact the PTS team and will ensure awareness and inclusion of the NRWS function with cross-functional stakeholders.
  • Supporting the Takeda Business and Center for External Innovation (CEI) by efficiently managing the documentation for the nonclinical due diligence process, asset in-licensing and divestiture processes in compliance with R&D IT, Strategy & Operations and Quality Assurance processes.


Job Function and Description


Leadership, management, and oversight of the Nonclinical Regulatory Writing & Submissions group staff.

  • Conducts line management and administrative function for the group; consistently evaluating group organizational structure (including FTE and contract/consulting staff), resource allocation and workload; provide prioritization of headcount needs, review job levels; initiate hiring and onboarding/offboarding
  • Responsible for career development planning, goal setting, and performance evaluation of direct reports.
  • Trains and mentors staff to foster development and expansion of collaborative roles and network; engages in cross-functional initiatives to support the Takeda organization
  • Demonstrates positive leadership - emphasizes teamwork and commitment; provides encouragement and resolution to support staff in a highly dynamic environment
  • Regularly provides updates in written and verbal format to PTS leadership team and upper-level management / cross-functional teams to showcase milestones/success and tracking of deliverables


Lead the planning, tracking, compilation and regulatory compliance of all nonclinical documentation for regulatory submissions:

  • Regularly liaises with various cross-functional teams (Clinical, Global Patient Safety, Program Management) and stakeholders (Global Regulatory Affairs, Regulatory Operations) as well as PTS project-team representatives to maintain a current submissions schedule, strategy and understanding of nonclinical documentation needs
  • Evaluates the capabilities and competencies of documentation vendors and consultants; is responsible for selection, training, oversight and resource allocation of third-party vendors for process support in provision of work overflow 
  • Provides on-boarding training, system access and submission tools to enable Regulatory submission activity for PTS organization
  • Liaises effectively with PTS functional leads and Regulatory Affairs/Operations to establish clear submission aims, content requirements and timelines
  • Leads documentation efforts and provides transparency of regulatory document lifecycle management to PTS organization on asset in-licensing and divestments
  • Works closely with PTS function leads (DSRE, DMPK, QTS, etc) to ensure appropriate input, review, approval and sign-off of documentation activities
  • Provides oversight and input to Drug Discovery Sciences and Discovery Research Therapeutic Area Teams (eg, Global Biologics) to manage transfer of Research reports required for submission into regulatory documents


Responsible for developing and maintaining process and quality standards for the format and content of nonclinical documents.

  • Works closely with PTS functional leads, Drug Discovery Sciences team and Regulatory Operations to define/develop Takeda templates and standards for the format and content of nonclinical study reports and submission documents.
  • Maintains awareness of changes in global Regulatory Authority nonclinical documentation requirements/expectations and ensures that Takeda’s standards are compliant; provides training and ensures alignment for PTS teams
  • Develops and maintains processes to ensure that Takeda standards for documentation, document transfer, version control and archiving are applied within PTS and by external vendors.
  • Oversight of system conformity, training adherence and alignment with GRA-IT (eg, EDMS maintenance of nonclinical documentation)
  • Serves as NRWS primary stakeholder in Global processes and initiatives that impact the PTS organization; provides both strategic and technical input on systems (eg, EDMS upgrades/harmonization, Global Core Dossier, effective submission planning)
  • Performs review of dossier/documentation and provides input within due diligence workstreams


Will provide a combination of direct and indirect supervision for the group of ~ 19 individuals

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be highlighted.)

  • Bachelors or Masters degree in a scientific field or related subject.
  • At least 10 years’ experience working in nonclinical sciences within the pharmaceutical industry
  • At least 5 years’ experience compiling nonclinical documentation or regulatory submissions.
  • Fluency in written and spoken English is required.

Key Skills, Abilities, and Competencies

  • Proven leadership skills with individuals having a wide range of experience
  • A broad understanding of the drug development process and a thorough understanding of regulatory requirements for the format, content and quality of nonclinical documentation.
  • Experience in process change and/or leading cross functional initiatives
  • Highly effective organizational and planning skill.
  • Effective interpersonal, oral and written communication skills
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenging new ideas, information, situations or criticism
  • Quickly learn technical components of systems & software to contribute to process review and create efficiencies to support staff
  • Ability to effectively engage with a wide variety of internal/external technical and business experts in a respectful and transparent fashion

Complexity and Problem Solving

  • Ability to quickly and efficiently resolve planning conflicts, manage multiple projects simultaneously and deal with rapidly changing priorities
  • Emphasize real-time communication, accountability and trust within department
  • Develop strategies for nonclinical submissions with relevant project teams and PTS functional leads, and obtain line alignment and approval
  • Notify line management of significant deviations from plans
  • Ability to rapidly assimilate/synthesize data and information from diverse sources, make judgments on complex/abstract problems and develop innovative solutions as necessary

Internal and External Contacts

Accountable to Head of PTS and routine interaction with heads of PTS functional groups (eg: DMPK, DSRE, QTS).  Engagement and frequent contact required with the following internal and external groups:

Internal:  Staff within PTS, Pharmaceutical Sciences, Regulatory Affairs, Regulatory Operations, Clinical Development, Clinical Operations, Project Management, Center for External Innovation, Quality Analytical Compliance, Global Patient Safety and others.  Non-R&D staff in Process Development, Quality Legal, Finance, others as needed.

External:  PTS vendors/CROs, scientific experts, contractors & consultants.

Must be customer-orientated with a good awareness of customer expectations

•    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

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Cambridge, MA

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Job ID R0023406

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