Head of Global Regulatory Affairs - Oncology

Company: Takeda Pharmaceutical
Location: Clifton
Posted on: September 22, 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 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 Head of Global Regulatory Affairs - Oncology where you will provide global regulatory oversight for the assigned therapeutic area, focused on non-clinical and clinical aspects of drug development and associated regulations. You will provide asset-level responsibility for both US and EU HA interactions and procedures (including direct reporting lines). -As part of the Global Regulatory Affairs team, you will report to the Head of Global Regulatory Affairs and provide core input to Global Program Team(s) throughout development programs. How you will contribute: Develop and implement innovative, competitive global regulatory strategies from product inception to end of lifecycle and primary interface with US Food and Drug Administration, overall responsibility for global regulatory strategies. Global Regulatory Leads represent GRA at GPT and lead Global Regulatory Teams (GRTs)--- Provide strategic regulatory input to global teams and regional cross-functional teams for new product filings and business initiatives Responsible for the development of regional regulatory strategies that de-risk and accelerate the registration of innovative and established medicines in the EU; primary interface with EMA--- Flawless execution of global registration strategies that enhance the likelihood of regulatory approval through the pursuit of novel regulatory pathways and continuous sponsor/regulatory dialog in support of EU and US business priorities Identify regulatory requirements and trends across therapeutic areas of responsibility, and provides regulatory guidance, and expertise to the global development team and/or higher governance bodies in these areas. Responsible for global regulatory development plans/strategies for all projects in TA scope (consolidated across JPN, US, EU, and ROW) including ensuring clinical trial requirements for global product approval are met. What you bring to Takeda: Minimum BS degree: advanced degree (MS, MBA, PhD or MD) preferred with 10+ years of industry experience in Regulatory Affairs development with responsibilities for major aspects of strategic planning, implementation, and delivery of clinical programs Extensive experience in interacting/negotiating with US (FDA) and EU (EMEA) agencies Senior management experience in Regulatory Affairs or related field, leading a medium to large organization and influencing senior-level management and key stakeholders Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables Operational experience in pharmaceutical drug development with significant direct exposure to clinical development Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions. Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy Base Salary Range: $240,100.00 to $343,000.00 , based on the candidate's 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. - - - 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 Programs 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. Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-CS1 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

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