Nonclinical Regulatory Writing and Submission Support, Sr. Manager

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Job Description

OBJECTIVES/PURPOSE  

• Develop, manage, and execute nonclinical regulatory writing in a variety of projects of diverse scope and complexity across multiple therapeutic areas, geographic regions and development phases. 

• 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. 

• Serve as the NRWS representative on cross-functional initiatives, when required. 

ACCOUNTABILITIES  

• Plan, author, review, update and manage nonclinical components of regulatory documents such as Briefing Books (BB), Investigator's Brochures (IBs), Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), Investigator's Brochures (IBs), New Drug Applications (NDAs), Biologic License Applications (BLAs), Marketing Authorization Applications (MAAs), responses to queries (RTQs), and various annual reports (DSUR, DSUR, PBRER) for drug products across Takeda's R&D portfolio (preclinical through marketed) and Takeda's major therapeutic areas (Oncology, Gastrointestinal & Inflammation, Neuroscience, Rare Disease) with a focus on First in Human (FIH) programs .  

• Apply advanced knowledge and experience to assess document requirements, develop writing strategy, compose drafts, identify information gaps or other potential issues, and facilitate document finalization for regulatory-compliant submissions, while ensuring alignment with International Conference on Harmonization (ICH) guidelines, regulatory requirements, and Takeda's policies and processes. 

• Understand and apply the principles of regulatory writing and lean authoring, writing with the audience in mind and conveying messages in a clear and concise manner when presenting pharmacology, pharmacokinetics and toxicology data and strategies.

• Lead nonclinical submission working groups to liaise effectively with cross-functional team members (Program Manageme