Manager, Global Regulatory Affairs, GI & Inflammation - Boston Massachusetts

Company: Initial Therapeutics, Inc.
Location: Boston, Massachusetts
Posted On: 05/05/2025

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionObjective / Purpose:

• Contributes to global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives.
• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
• May communicate with FDA as required.Accountabilities:
  • The Manager role includes managing one or more projects with less complexity. May support GRL on more complex programs. May lead working groups, and represents Global Regulatory Team (GRT) at project team meetings. Provides strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
  • Ensure or assist in ensuring that regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs.
  • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
  • Contributes to Health Authority submissions and approvals for project(s) within scope. The Manager may lead less complex multi-function submissions, such as original INDs or support GRLs for more complex submissions, including major global marketing applications.
  • Assists and attends FDA and other agency meetings.
  • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
  • Attends study team meetings and provides regulatory guidance.
  • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
  • May participate on departmental task-forces or initiatives.
  • Partner with functions responsible for ensuring market access and regional GRA leads to understand market access topics and strategize opportunities to strengthen product development plan(s) and build into global integrated regulatory strategy.Education & Competencies (Technical and Behavioral):
    • Bachelor's Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline preferred.
    • A minimum of 2 years of pharmaceutical industry experience. This is inclusive of 1 year of regulatory experience or combination of 2 year regulatory and/or related experience.
    • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
    • Basic working knowledge of drug development process and regulatory requirements.
    • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
    • Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
    • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
    • Must work well with others and within global teams.
    • Able to bring working teams together for common objectives.
    • Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.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:Boston, MAU.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 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-term incentives. 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 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, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt 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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