Lead, Regulatory Intelligence and Policy Research

Company: Takeda Pharmaceutical
Location: Shortsville
Posted on: November 25, 2022

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 DescriptionAt 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 also Support global coordination for Takeda subject matter expert participation on external workstreams and trade groups. Support global coordination of Takeda Guidance commenting and tracking, including region, country-specific, and ICH / multi-national guidances and regulations. As well as drive effective coordination and representation to ensure a Takeda one voice policy.How you will contribute:

• Global regulatory intelligence contact for key stakeholders including therapeutic areas and regional teams as determined in collaboration with regional EU, US, Japanese and EM Regulatory Intelligence colleagues.
• 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. Work with Takeda colleagues to publish research when appropriate.
• Support global coordination for Takeda subject matter expert participation on external workstreams and trade groups. Support global coordination of Takeda Guidance commenting and tracking, including region, country-specific, and ICH / multi-national guidances and regulations. Drive effective coordination and representation to ensure a Takeda one voice policy.
  • Represent Global Regulatory Policy & Intelligence and Global Regulatory Affairs on internal and external forums/networks as assigned. Provides impactful summaries and strategic advice, back to the business, regarding assigned internal/external activities. Provides leadership to influence the regulatory environment to meet business needs.
    • Conduct strategic assessments of external regulatory changes globally and work with subject matter experts within the Company, to support the decision-making process to understand and prioritise the regulatory risk & opportunities globally: develop the strategies/positions and drive for appropriate action(s) relevant to Takeda's Therapeutic Areas of focus and development projects.
      • Contribute to the development and execute the Regulatory Intelligence strategy. Keep abreast of internal and external changes, trends, development and other dynamics relevant to the regulatory environment that may impact Takeda's regulatory and/or access strategies and disseminate information.
      • Contribute to and lead the development and implementation of appropriate regulatory intelligence management systems, processes, and standards within GRPI, GRA, and across Takeda as assigned, including vendor management and internal change control.
      • Work closely and partner with GRPI colleagues and Subject Matter Experts to plan and execute regulatory advocacy positions, strategies and tactics and facilitate engagement on key topics of interest.
      • Support metrics development and maintain consistent oversight of deliverables across GRPI. Keep all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level.
      • Responsible for demonstrating Takeda Leadership Behaviors.
      • Strong data science and data analysis skillsets, including dataset identification and integration, data visualization, and data interpretation;
      • Proficient in Python or R
      • Strong familiarity with key public drug development and regulatory datasets - clinicaltrials.gov, dailymed.gov, drugs@FDA, EPAR, others - is prefered. Minimum Requirements/Qualifications:
        • BSc, Advanced scientific related degree preferred; BA accepted based on experience.
        • A minimum of 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.
        • Solid understanding of 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 a good understanding of basic regulatory requirements and emerging markets. Sound knowledge of intelligence tools and methods.
        • Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for region. Proven track record working with a major regulatory agency, specific experience in government or policy is also desired.
        • Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering timelines. Proven success at stakeholder engagement across organizational levels and boundaries.
        • Must have good working knowledge in 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.
        • Generally strong in working well with others, within global teams and communicating with senior leadership.
        • Experience in 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 reimbursementMore 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.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.Base Salary Range: $137,200 to $196,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seqIn accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #LI-Remote

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