Director/Senior Director, Global Regulatory Lead - Rare Diseases (Gene Therapy)

Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: January 26, 2023

Job Description:

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 Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director/Senior Director, Global Regulatory Lead in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director/Senior Director working on the Global Regulatory Affairs Development team, you will be empowered to l ead the global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives, and a typical day will include: OBJECTIVES:

• Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
• Provides strategic regulatory advice on the clinical development of gene therapy products, including interpretation of final and draft regulatory guidance regarding manufacturing considerations, specific disease therapeutic targets (eg, neurodegenerative diseases), and sameness of gene therapy products under the orphan drug regulations
• Keeps abreast of new developments in gene therapy and maintains oversight on the rapidly evolving regulatory landscape and advancing innovations in the development of gene therapy products.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
• Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Represents Takeda as applicable in industry/regulatory forums to lead regulatory innovation. ACCOUNTABILITIES:
  • The Director/Senior Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
  • 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.
  • Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
  • Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director/Senior Director will lead all submission types.
  • Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
  • 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.
  • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
  • Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
  • Lead regulatory reviewer in due diligence for licensing opportunities.
  • Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
  • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
  • Responsible for demonstrating Takeda leadership behaviors EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
    • BSc or Advanced Degree, preferred. BA accepted.
    • 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience or combination of 6+ years regulatory and/or related experience.
    • Understanding of the regulatory framework for the clinical development and manufacturing of gene therapy products leading to global marketing authorizations. Ability to advice on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice.
    • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
    • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
    • Strong 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. PHYSICAL DEMANDS:
      • Manual dexterity required to operate office equipment (ie computers, phones, etc.).
      • Carrying, handling and reaching for objects.
      • Ability to sit or stand for long periods of time while traveling.TRAVEL REQUIREMENTS:
        • Willingness to travel to various meetings, including overnight trips.
        • Requires approximately up to 10-30% travel.WHAT TAKEDA CAN OFFER YOU:
          • 401(k) with company match and Annual Retirement Contribution Plan
          • Tuition reimbursement
          • Company match of charitable contributions
          • Health & Wellness programs including onsite flu shots and health screenings
          • Generous time off for vacation and the option to purchase additional vacation days
          • Community Outreach ProgramsEmpowering Our People to ShineLearn more at .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. Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Cambridge , Director/Senior Director, Global Regulatory Lead - Rare Diseases (Gene Therapy), Executive , Cambridge, Massachusetts