US Head, Global Regulatory Policy and Innovation

Company: Takeda Pharmaceutical
Location: Clifton
Posted on: March 11, 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 About 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 US Head, Global Regulatory Policy and Innovation where you will serve as US Head for regulatory policy and advocacy activities, and US regulatory intelligence lead for therapeutic areas and regional teams as determined in collaboration with regional US, Japan, China and Global Regulatory Research and Intelligence colleagues. - Lead and develop company relationships with key regulatory agencies in the US regions with a focus on rare disease development, regenerative medicines, digital and data regulatory issues (incl. RWE), patient focused drug development, clinical development, and life-cycle management. - Lead team of 3 to 4 FTEs globally regarding policy and advocacy activities and work collaboratively with EUCAN, Japan, and China colleagues to deliver a work plan to meet that vision. Work with Global Regulatory Policy and Innovation (GRPI) team to create global and regional vision for drug development and regulatory environment. -Also works closely with the Regional Policy leads to drive success at the regional regulatory interface. With GRPI colleagues you will define and oversee the systems/processes to monitor the regulatory environment for changes that may have an impact on Takeda's products and goals. As such bring functional excellence to Global Regulatory Policy and Innovation. Drive best practices and excellence in execution within the department and cross-functionally. Utilizing your experience to oversee the strategic assessment of external regulatory changes globally and, to work with subject matter experts within the Company, to drive or support the decision-making process to understand and prioritize the regulatory risks & opportunities globally: - the internal impact analyses, development of strategies/ positions and drive for appropriate action(s) relevant to Takeda's Therapeutic Areas of focus and development projects. As part of the Global Regulatory Policy and Innovation, you will report to the Head, Global Regulatory Policy and Innovation. How you will contribute: Lead Global Regulatory Policy & Innovation, GRA, and Takeda on US-focused 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. Oversee GRA and R&D participation in US trade associations and pre-competitive consortia to drive effective networking and representation to ensure a one voice policy. - Lead the development and execution a regulatory intelligence strategy for US region. Keep abreast of internal and external changes, trends, developments, and other dynamics relevant to the regulatory environment that may have impact to Takeda's regulatory and access strategies and propose action plan. With GRPI colleagues, develop a US regulatory policy and advocacy strategy for Takeda. Work closely and partner with GRPI colleagues globally, as well as subject matter experts, and Public Affairs to build regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest. - Oversee and have primary accountability/responsibility for the management and maintenance of special projects such as US Regulatory Affairs Priority Topic list, position papers, and regulatory issues/trends reports, as assigned. Maintain consistent oversight of deliverables. Keep GRA management and 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. Lead routine and ad hoc meetings within function and cross-functionally.--- Presents to senior management as relevant. Leads personnel within the US to ensure coverage for regional responsibilities; Elevates needs when necessary. Minimum Requirements/Qualifications: BS - PhD, JD, MD, PharmD or equivalent strongly preferred. A minimum of 15 years pharmaceutical industry or regulatory agency experience. - This is inclusive of 5 years regulatory experience or a combination of 10 years of regulatory and/or related experience in both development and post-marketing phases. Thorough Knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, with a focus on US and FDA, with a good understanding of basic regulatory requirements in other global markets (Japan, EU, China). Sound knowledge of intelligence tools and methods. Strong network with regulatory-focused trade associations, (e.g. BIO, PhRMA, FOCR, Duke Margolis) and knowledge of US regulatory agency structure and leadership. 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 the region. Proven track record working with a major regulatory agency, specific experience in government affairs 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 to timelines. Proven success at stakeholder engagement across organizational levels and boundaries. Must be strong overall and able to train/develop staff in the area of regulatory intelligence and policy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory trends and offers risk mitigation strategies. Ability to develop regulatory strategy to balance short and long term objectives, and support GRLs/regional regulatory leads to drive teams to make decisions and achieve deliverables within agreed parameters and timescales. Must be strong leader, working well with others, within global teams and communicating with senior leadership. Must be strong leader that creates vision for group. - Inspires and motivates group. - Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff. Experience in managing personnel required; experience managing relationships with CROs and/or contractors also preferred. Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 10-30%. 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 reimbursement 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. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $194,000 - 278,000, 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 Pa

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