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Director, Nonclinical Regulatory Writing and Submission Support, Team Lead

Employer
Takeda
Location
Remote
Start date
Feb 4, 2025
View more categoriesView less categories
Discipline
Regulatory, Regulatory Affairs
Required Education
Doctorate/PHD/MD
Position Type
Full time

Job Details

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

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 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.

#LI-Remote

Company

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.

 

Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future

For more information, visit https://jobs.takeda.com/

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
United States

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