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Associate Director - Regulatory Strategy - Oncology

Company: Takeda
Location: Cambridge
Posted on: January 16, 2022

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 an Associate Director, Global Regulatory Affairs Strategy - Oncology in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.

  • To provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
  • To be a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.
  • To provide leadership and development of colleagues responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
    • Lead the global regulatory subteam (GRT) and represents the GRT at GPT, cross-functional subteams and working groups.
    • Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees junior staff responsible.
    • Responsible for independently achieving submissions, including major submissions (NDA/BLA/MAA); may oversee staff in achieving major submissions.
    • Oversee multiple projects and manage individual projects.
    • For the project(s) of responsibility, collaborates with EU, Japan and/or other regional counterparts in compiling global regulatory strategies and ensures critical deliverables to territories outside the US to ensure regional execution of the strategy.
    • Identifies regulatory strategies and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
    • Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings.
    • Represent the product regulatory team on cross-functional subteams and working groups.
    • 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.
    • Lead regulatory review in due diligence for licensing opportunities.
    • Provides oversight to ensure regulatory compliance of marketed products.
    • Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
    • 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.
      • BSc Degree preferred. BA accepted
      • Advanced Degree preferred
      • A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience.
      • Oncology experience would be an asset
      • Solid working knowledge of drug development process and regulatory requirements, knowledge of FDA., EU, and Japan. Knowledge of China, emerging markets, and post-marketing a plus.
      • Experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
      • Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
      • Strong oral and written communication skills and negotiation skills
      • Works well with others and within global teams
      • Skilled 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.
      • Strong leader who is an effective manager and is able to bring working teams together for common objectives.
        • Willingness to travel to various meetings or client sites including overnight trips. Some international travel may be required.
        • Requires approximately 10 % travel.
          • 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 Programs
            Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
            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.

Keywords: Takeda, Cambridge , Associate Director - Regulatory Strategy - Oncology, Healthcare , Cambridge, Massachusetts

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