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Head of Global Regulatory Operations
1 month ago
We are seeking a seasoned professional to lead our Global Regulatory Operations team. As the Head of Regulatory Operations, you will be responsible for formulating and implementing the vision and strategy for our Regulatory Affairs Operations organization.
Key Responsibilities- Develop and implement a digital innovation ecosystem across GRA, R&D, and the enterprise.
- Influence and drive external regulatory standards through strategic partnerships with regulators, trade groups, and technology/BPO vendors.
- Provide strategic thought leadership to the Head of Regulatory and other stakeholders on complex problems, initiatives, strategies, and budgets.
- Lead the development and maintenance of a Regulatory Affairs Quality Management System, including training and compliance programs.
- Build and maintain a communication strategy and platform for all staff across the organization.
- Ensure timely dissemination of regulations, guidelines, and data to Global Regulatory Affairs staff.
- Develop and implement an employment culture and values that attract, retain, and develop the most effective people.
- Ensure conformance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
- Minimum BS degree; advanced degree (MS, MBA, PhD, or MD) preferred with 15+ years of industry experience in and or around drug development.
- Senior management experience in pharmaceutical or related field, leading a medium to large organization and influencing senior-level management and key stakeholders.
- Proven 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.
- History of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams.
- Experience managing complex global partnerships and innovation ecosystems.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
We offer a competitive salary range of $252,000.00 to $396,000.00, as well as a comprehensive benefits package, including medical, dental, vision insurance, a 401(k) plan, and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
We are an equal opportunity employer and welcome applications from diverse candidates. We are committed to creating a diverse and inclusive workplace and are proud to be an EEO employer.
