Nonclinical Regulatory Writing and Submission Support, Sr. Manager

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Job Description

OBJECTIVES/PURPOSE

• Develop, manage, and executenonclinicalregulatory writing in a variety of projects of diverse scope and complexityacross multiple therapeuticareas, geographicregions and developmentphases.

• 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&Dportfolio (preclinical through marketed) and Takeda's major therapeutic areas (Oncology, Gastrointestinal & Inflammation, Neuroscience, Rare Disease) with a focus on First in Human (FIH) programs .

• Applyadvanced knowledge and experience to assessdocumentrequirements, develop writing strategy, compose drafts, identify information gaps or otherpotentialissues, and facilitate documentfinalization for regulatory-compliantsubmissions, whileensuringalignment with International Conference on Harmonization (ICH) guidelines, regulatoryrequirements, 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 Management, Global Regulatory Affairs, 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.

• Represent NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs, Regulatory Operations) to plan, generate, manage, finalizeand communicate about nonclinical documents for regulatory submissions. Generate nonclinical timelines. Liaise effectively with cross-functional team members to communicate aims, content requirements, and timelines.

• Implement and drive continuous improvement by integrating automation, innovative practices and new technologies including AI/GenAI and RPA into the technical and regulatory writing framework, streamlining document life cycle management processes and fostering an environment of forward-thinking excellence.

• Develop practical timelines (Microsoft Project) for deliverables

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Ph.D. or M.Sc. in scientific field (e.g., biology, pharmacology, toxicology), with minimum of 8 years of experiencewith nonclinical regulatory writing within the pharmaceutical industryor Contract Research Organization (CRO).

• Significantexperience in direct authoring of nonclinicalsummarysections to support regulatorysubmissions, includingbutnot limited to IBs, briefing books, INDs (including FIH), periodic reports, NDAs/MAAs/BLAs, and agency responses to queries.

• Experience in drug product development across numerous modalities (small molecule, biologics, cell therapies, etc.), with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokineticsdemonstrating a broad understanding of the drug development process (from preclinical through post-marketing stages).

• Experience in 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.

• 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.) and ability to interpret and apply these guidelines. Regulatory Affairs Credential (RAC-Drugs) is an advantage.

• 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.

• Details oriented with strong verbal, written, and interpersonal communication skills,active listening, and influencing skills; establishes and maintains professional and productive working relationships with internal and external stakeholders.

• Possession of innovative problem-solving skills and developability to impact outcomesthroughinfluence, notdirect authority.

• Ability to operate in a fast-paced environment and manage multiple activities, priorities, and deadlines and willingness to broaden knowledge in complementary fields

• Ability to rapidly adjust to new, unknown, and/or challenging situations is mandatory.

• Demonstratedability to work in a global ecosystem (internal and external) with a high degree of complexity.

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:

$133,000.00 - $209,000.00

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 applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

LocationsMassachusetts - Virtual

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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