Takeda Pharmaceuticals
Associate Director, Nonclinical Regulatory Writing and Submission Support
Takeda Pharmaceuticals, Honolulu, Hawaii, United States, 96814
Takeda Pharmaceuticals Associate Director, Nonclinical Regulatory Writing and Submission Support Honolulu, Hawaii Apply Now
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’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAssociate Director, Nonclinical Regulatory Writing and Submission Support,
Gastrointestinal and Inflammation (GI2) and Neuroscience (NS) ProductsAt 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,
GI2 and NS 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 (ONC), GI2, and NS. The NRWS team is a goal- and results-driven team, and we are strong believers in innovation and streamlined processes.How you will contribute:ACCOUNTABILITIESProvides 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
Gastrointestinal and Inflammation (GI2) and Neuroscience (NS)
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, PBRER) and nonclinical technical reports for drug products across Takeda's R&D portfolio.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 to ensure regulatory compliance.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).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.Serves as the NRWS representative on cross-functional initiatives, when required.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.Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics.Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions.Experience in drug product development across numerous modalities (small molecule, biologics, cell therapies, etc.).Experience in program management, with ability to prioritize and manage multiple programs within strict regulatory/compliance deadlines.Possess innovative problem-solving skills and develop ability to impact outcomes through influence.Thorough understanding of regulatory guidelines related to global submissions.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.Demonstrated ability to work in a global ecosystem with a high degree of complexity.Demonstrated ability to see and understand a broader, enterprise level perspective.ADDITIONAL INFORMATIONThe 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).Takeda Compensation and Benefits SummaryWe 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 - VirtualU.S. Base Salary Range:$108,500.00 - $170,500.00The 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.EEO StatementTakeda 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.
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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’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAssociate Director, Nonclinical Regulatory Writing and Submission Support,
Gastrointestinal and Inflammation (GI2) and Neuroscience (NS) ProductsAt 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,
GI2 and NS 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 (ONC), GI2, and NS. The NRWS team is a goal- and results-driven team, and we are strong believers in innovation and streamlined processes.How you will contribute:ACCOUNTABILITIESProvides 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
Gastrointestinal and Inflammation (GI2) and Neuroscience (NS)
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, PBRER) and nonclinical technical reports for drug products across Takeda's R&D portfolio.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 to ensure regulatory compliance.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).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.Serves as the NRWS representative on cross-functional initiatives, when required.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.Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics.Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions.Experience in drug product development across numerous modalities (small molecule, biologics, cell therapies, etc.).Experience in program management, with ability to prioritize and manage multiple programs within strict regulatory/compliance deadlines.Possess innovative problem-solving skills and develop ability to impact outcomes through influence.Thorough understanding of regulatory guidelines related to global submissions.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.Demonstrated ability to work in a global ecosystem with a high degree of complexity.Demonstrated ability to see and understand a broader, enterprise level perspective.ADDITIONAL INFORMATIONThe 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).Takeda Compensation and Benefits SummaryWe 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 - VirtualU.S. Base Salary Range:$108,500.00 - $170,500.00The 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.EEO StatementTakeda 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.
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