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

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 Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on strategy, define executable timelines, and agree upon content for nonclinical regulatory submissions.
• Represents NRWS on cross-functional project teams to plan and communicate about nonclinical regulatory submissions.
• Understands and applies 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.
• Serves as the NRWS representative on cross-functional initiatives, when required.
• Develops practical timelines (Microsoft Project) for deliverables.

Minimum Requirements/Qualifications:

• Ph.D. in scientific field (e.g., pharmacokinetics, pharmacology, toxicology), with minimum of 10 years of leadership experience with nonclinical regulatory writing within a pharmaceutical company or Contract Research Organization (CRO)
• Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process. 
• Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions, including but not limited to IBs, briefing books, INDs, periodic reports, NDAs/MAAs/BLAs, and agency responses to queries.
• Experience in drug product development across numerous modalities (small molecule, biologics, cell therapies, etc.), demonstrating a broad understanding of the drug development process (from preclinical through post-marketing stages). 
• Experience in a program management, with ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines, and lead internal/external and scientific teams to regulatory submission aims.
• Possess innovative problem-solving skills and develop ability to impact outcomes through influence, not direct authority.
• Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g., FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.).
• Regulatory Affairs Credential (RAC-Drugs) is an advantage.
• Strong verbal, written, and interpersonal communication skills.
• Learning and understanding new therapeutic areas and regional regulatory requirements quickly and comprehensively.
• Demonstrated ability to work in a global ecosystem (internal and external) with a high degree of complexity.
• Demonstrated ability to see and understand a broader, enterprise level perspective

ADDITIONAL INFORMATION

• The vast majority of project meetings are scheduled based on Eastern Time standard working hours (8am – 5pm ET).
• Although this position is remote, occasional face-to-face meetings may be important to attend (no more than quarterly, likely in Boston, MA).