Director, Nonclinical Regulatory Writing and Submission Support, Team Lead

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Objective / Purpose:

• Member of the Nonclinical Regulatory Writing and Submissions (NRWS) leadership who drives NRWS vision and mission.
• Manage the nonclinical internal writing team including writers and quality control reviewers, and functional service providers (FSPs) to meet corporate goals and successfully execute on high-quality deliverables across all programs and development phases.
• Spearheaded a culture of innovation across NRWS and Takeda by introducing cutting-edge tools and technologies including robotic process automation (RPA) and AI/GenAI, to enhanced departmental performance, operational efficiency and accelerated cycle times.
• Apply advanced knowledge of relevant regulatory requirements and corporate policies, as well as work experience, to assess document requirements and identify information gaps or other potential issues. Ensure nonclinical regulatory documents adhere to standards and regulatory guidelines.
• Mentor and guide writing team members, fostering a supportive environment that promotes continuous learning, inclusivity, and professional growth.
• Represent NRWS in cross functional initiatives.

Accountabilities:                                                                                                                                                                  

• Execute NRWS’ strategic vision and establish structure for high-quality deliverables across all programs and meet corporate goals by managing nonclinical regulatory writing activities.
• Represent NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs (GRA), Regulatory Operations) to plan, generate, manage, and finalize nonclinical documents for regulatory submissions. Generate nonclinical timelines. Liaise effectively with cross-functional team members to communicate aims, content requirements, and timelines.
• Represent NRWS on nonclinical cross-functional teams, working in close partnership with Global Regulatory Affairs (GRA) and nonclinical subject matter experts (SMEs) from pharmacology, drug metabolism, pharmacokinetics and modeling (DMPK&M), drug safety research and evaluation (DSRE), the drug discovery units (DDUs) functions and external collaborators.
• Lead the planning, tracking, compilation, and regulatory compliance of nonclinical technical and regulatory components to support Takeda’s Research and Development (R&D) portfolio.
• Develop and implement harmonized best practices, standard operation procedures (SOPs), job aids and other tools, ensuring consistency, quality, and operational excellence across the team.
• Direct involvement in authoring and reviewing nonclinical sections of regulatory documents, such as but not limited to Investigator's Brochures (IBs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs).
• Demonstrate and apply advanced knowledge of relevant regulatory requirements and corporate policies, as well as work experience, to assess document requirements and identify information gaps or other potential issues. Ensure nonclinical regulatory documents adhere to standards, regulatory guidelines and Takeda requirements and policies.
• Champion continuous improvement by integrating automation and innovative practices into the technical and regulatory writing framework, streamlining processes and fostering an environment of forward-thinking excellence.
• Manages the team related internal staffing and performance management, including hiring,