Director, US Regulatory Intelligence & Policy Lead

Daiichi Sankyo US

86d • $189,520 - $284,280

About The Position

This role is an integral member of the Daiichi Sankyo (DS) Global Regulatory Intelligence & Policy, Center of Excellence (GRIP CoE), and is responsible for leading US regulatory intelligence acquisition, analysis, communication, and knowledge management, as well as leading US regulatory advocacy and policy activities for assigned issue sets. The role will work closely with the Vice President, Head of North America Regulatory Affairs, other regional Regulatory Intelligence & Policy (RIP) Leads, and cross functional stakeholders, and will conduct analyses and targeted advocacy via a global lens that ensures US intelligence and policy activities are globally coordinated and globally aligned to achieve maximum impact for patients and Daiichi Sankyo business. Additionally, this role will be responsible for the management and continuous improvement of the GRIP CoE Hub designed to provide global access to critical RIP information and resources.

Requirements

• Bachelor's degree in medicine, life sciences, health or related field required.
• 7 or more years' experience in biopharma Regulatory Affairs, with at least 3 years developing regulatory strategies.
• 4 or more years' experience leading and executing Regulatory Intelligence (RI) & Policy activities in the U.S.
• Strong experience and working relationships across FDA and PhRMA highly desirable.
• 1 or more years experience working with international teams.
• 1 or more years experience of working with the global regulatory landscape for at least 2 of the following: Oncology drugs, Biologics/ADCs Companion diagnostics.

Nice To Haves

• Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred.
• Strong understanding of cross-cultural environments and different business practices across key markets.

Responsibilities

• Lead the acquisition, analysis, communication, and knowledge management of US regulatory intelligence (RI).
• Interpret, analyze, and apply US regulatory intelligence to inform strategic decisions of asset teams and leadership.
• Lead the strategic development and implementation of an assigned project portfolio for identifying, analyzing, and leveraging changes in the regulatory landscape.
• Transform regulatory information into actionable insights specific to Daiichi Sankyo.
• Contribute US regulatory intelligence content and perspective into deliverables.
• Deliver insightful and proactive RI and analysis.
• Leverage RI analyses to inform strategic decisions at both asset and above asset levels.
• Develop and maintain strong collaborative networks/relationships with cross-functional subject matter experts.
• Lead the development, implementation, maintenance, and continuous improvement of assigned elements of GRIP infrastructure.
• Identify and establish a focused set of US Regulatory Policy priorities for external engagement.
• Develop US regulatory policy/position papers in partnership with Daiichi Sankyo subject matter experts.
• Develop and execute strategic advocacy plans to achieve policy-shaping objectives.

Benefits

• 401k
• health_insurance
• dental_insurance
• vision_insurance
• life_insurance
• disability_insurance
• paid_holidays
• tuition_reimbursement
• professional_development
• employee_stock_purchase_plan

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees