Associate Director, Nonclinical Regulatory Writing and Submission Support, Oncology and Marketed Products

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Job Description

About the role:

Associate Director, Nonclinical Regulatory Writing and Submission Support, Oncology and Marketed Products

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Are you looking for a patient-focused, innovation-driven company that enables you to engage in meaningful work? Join us as an Associate Director - Nonclinical Regulatory Writer and Submission Support reporting to the Nonclinical Regulatory Writing and Submission Support, Oncology and Marketed Products. Team lead, based in Cambridge, MA/Virtual.

Here, you will be a vital contributor to our inspiring, bold mission.

As an Associate Director in the Nonclinical Regulatory Writing and Systems (NRWS) Department within Preclinical and Translational Sciences (PTS), you will be contributing to this science driven, collaborative and dynamic environment, bringing experience to add further value to the NRWS contribution to the PTS organization and to Takeda, with involvement in a variety of projects of diverse scope and complexity, reflecting the breadth of Takeda’s portfolio, including Oncology, Gastrointestinal and Inflammation, and Neuroscience. The NRWS team is a goal- and results-driven team, and we are strong believers in innovation and streamlined processes.

How you will contribute:

ACCOUNTABILITIES 

• Provides nonclinical regulatory writing expertise and mentorship to NRWS and Research and Development (R&D) staff members.
• Involves in a variety of projects of diverse scope and complexity, across all developmental stages (pre-development through post-marketing) and Takeda’s major therapeutic areas with focus on Oncology programs and Marketed Products across Takeda’s portfolio.
• Applies 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 submissions.
• Plans, authors, revises, updates and manages nonclinical components of regulatory documents such as Briefing Books (BB), 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), various annual reports (DSUR, DSUR, PBRER) and nonclinical technical reports for drug products across Takeda's R&D portfolio (preclinical through marketed) and Takeda's major therapeutic areas with a focus on First in Human (FIH) Oncology programs and marketed products undergoing rapid market expansions.
• Analyzes, interprets and distills nonclinical data to independently write and/or edit nonclinical documents. Ensures alignment with International Conference on Harmonization (ICH) guidelines, regulatory requirements and Takeda’s policies and processes.
• Applies advanced knowledge of relevant regulatory requirements and corporate policies, as well as work experience, to ensure regulatory compliance by assessing document requirements and identify information gaps or other potential issues.
• Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug