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Lead, Regulatory Intelligence and Policy Research

Company: Takeda Pharmaceutical
Location: Hempstead
Posted on: November 18, 2021

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At 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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a Lead, Regulatory Intelligence and Policy Research where you will be the global lead for regulatory policy research, including case studies, data-driven policy support, regulatory data analysis, visualization, and interpretation, public dataset identification and characterization, and hypothesis testing. You will also support global coordination for Takeda subject matter expert participation on external workstreams and trade groups. As part of the Global Regulatory Policy and Innovation team, you will report to the Senior Director and work with key stakeholders including therapeutic areas and regional teams as determined in collaboration with regional EU, US, Japanese and EM Regulatory Intelligence colleagues.How you will contribute:

  • Support global coordination of Takeda Guidance commenting and tracking, including region, country-specific, and ICH/multinational guidances and regulations. Drive coordination and representation to ensure a Takeda one voice policy.
  • Represent Global Regulatory Policy & Intelligence and Global Regulatory Affairs on all forums/networks as assigned. Provide impactful summaries and strategic advice back to the business regarding assigned activities. Provide leadership to influence the regulatory environment to meet business needs.
  • Conduct strategic assessments of external regulatory changes globally and work with experts within the Company, to support the decision-making process to understand and prioritize the regulatory risk & opportunities globally: develop the strategies/positions and achieve appropriate action(s) relevant to Takeda's Therapeutic Areas of focus and development projects.
  • Contribute to the development, and execute the Regulatory Intelligence strategy. Remain current on all changes, trends, development and other dynamics relevant to the regulatory environment that may impact Takeda's regulatory and access strategies and share information.
  • Lead and contribute to the development and implementation of regulatory intelligence management systems, processes, and standards within Global Regulatory Policy and Innovation, Global Regulatory Affairs, and across Takeda as assigned, including vendor management and internal change control.
  • Work and partner with Global Regulatory Policy and Innovation colleagues and Experts to plan and execute regulatory advocacy positions, strategies and facilitate engagement on important topics of interest.
  • Support metrics development and maintain oversight of deliverables across Global Regulatory Policy and Innovation. Keep all internal customers, and partners up to date with progress and provide interim updates on ongoing activities and current projects. Ensure issues are escalated when needed and encourage resolution at the appropriate level.
  • Demonstrate Takeda Leadership Behaviors.What you bring to Takeda:
    • BSc, Advanced scientific related degree preferred; BA accepted based on experience.
    • 8 years of pharmaceutical industry experience. This is inclusive of 6 years regulatory experience or a combination of 8 years regulatory and/or related experience in both development and post-marketing phases.
    • Experience with regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role), with an understanding of basic regulatory requirements and emerging markets. Sound knowledge of intelligence tools and methods.
    • Experience working with different data modalities, structured and unstructured data sets, and automated / AI-driven mechanisms for data analysis and interpretation.
    • Understand and interpret complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for region. Track record working with a major regulatory agency, specific experience in government or policy.
    • Excellent collaboration, influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills and managing and adhering timelines. Experience at partner engagement across organizational levels and boundaries.
    • Have good working knowledge in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation strategies.
    • Working well with others, within global teams and communicating with senior leadership.
    • Experience managing relationships with CROs and/or contractors also preferred.What Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • 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 and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursementLocation and Salary Information:
        • This job posting excludes CO applicants.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering our people to shine: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.#LI-LC1Absent 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.LocationsUSA - DC - WashingtonBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Hempstead , Lead, Regulatory Intelligence and Policy Research, Other , Hempstead, New York

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