Director, Nonclinical Regulatory Writing and Submission Support, Team Lead

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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, training, coaching and performance reviews. Lead or support training initiatives within the department and across R&D, and support maintenance of a balanced workload among nonclinical writers.

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

Education & Competencies (Technical and Behavioral):

• Ph. D. in scientific field (e. g. , pharmacokinetics, pharmacology, toxicology), with minimum of 12 years of experience with nonclinical and/or scientific writing within the pharmaceutical industry. A minimum of 3 years of managerial experience is a must.

• 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 (including FIH), periodic reports, NDAs/MAAs/BLAs, and agency responses.

• Forward thinking and passionate about driving innovation and continuous improvement who excels at identifying, testing, and implementing new technologies to enhance our writing framework.

• Demonstrate digital dexterity.

• Experience with regulatory submissions for new modalities (e. g. , cell therapies) is an advantage.

• Experience in a program management-type role; ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and lead internal/external and scientific teams to regulatory submission aims.

• Thorough understanding of regulatory guidelines related to global submissions and submission content (e. g. , FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements).

• Possession of innovative problem-solving skills and develop ability to impact outcomes through influence, not direct authority.

• Possession of strong verbal, written, and interpersonal communication skills.

• Demonstrated ability to work in a fast-changing global ecosystem (internal and external) with a high degree of complexity.

• Demonstrated ability to see and understand a broader, enterprise level perspective.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U. S. Base Salary Range:

$169,400. 00 - $266,200. 00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the .