Head Regulatory Operations - Full-time / Part-time

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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 Head Regulatory Operations where you will provide strategic and operational leadership to lead collaboration across Global Regulatory Affairs functions, develop long-term vision and MRP and support achievement of Key Performance Initiatives (KPI). You will also develop overall strategic planning process and ensuring execution of executive strategic plans, projects and commitments which drive top and bottom line growth. As part of the Global Regulatory Affairs team, you will report to the Head of Global Regulatory Affairs and align functional implementation strategies and plans with other functions within R&D and other key divisional or corporate initiatives.

Objectives:

• Develop and execute analytical and tactical strategies to ensure business projects, milestones and policies are completed.

• Develop and lead the Global Regulatory Affairs Quality Management System and processes, regulatory communication and change management strategy, strategic initiatives, overall planning and regulatory metrics.

• Oversee External Affairs support, KPI and FY goals- management, and internal and external communications.

How you will contribute:

• Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of the department.

• Monitor progress toward Functional KPIs, intervening as necessary to ensure that the functions are on track to meet or exceed its performance targets. Provide complex analysis and insight in evaluating overall functional performance over time and for future planning.

• Serve as a member of the Global Regulatory Affairs Leadership team, giving input to key strategic, portfolio, human capital and financial decisions.

• Be a strategic thought partner to the Head of Regulatory, with regard to complex problems, current and future initiatives, strategies, and budgets. Look across teams to identify synergies and interdependencies to ensure optimal working model across all regulatory sites/functions.

• Develop and maintain a Regulatory Affairs Quality Management System including a system for providing appropriate worldwide training.

• Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to Global Regulatory Affairs staff via team sites or intranet.

• Help create and communicate an employment culture and values which attract, retain, and develop the most effective people.

• Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.

What you bring to Takeda:

• Minimum BS degree; advanced degree (MS, MBA, PhD or MD) preferred with 15+ years of industry experience in and or around drug development with responsibilities for major aspects of strategic planning, implementation and project management.

• Senior management experience in pharmaceutical 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.

• Health care business acumen with a comprehensive understanding of the pharmaceutical industry

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

Location 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.

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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 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.

LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time