Director, US Regulatory Intelligence & Policy Lead

Daiichi Sankyo; United States; Remote; USD 189,000 - 285,000; Full time

Job summary

A global pharmaceutical company is seeking a Regulatory Intelligence & Policy Lead in the US. The role involves leading regulatory intelligence and advocacy efforts to enhance drug development and approval processes. Candidates should have extensive experience in biopharma regulatory affairs and a strong understanding of US FDA policies. This position offers a competitive salary range of $189,520.00 - $284,280.00.

Qualifications

• 7+ years in biopharma Regulatory Affairs with regulatory strategy experience.
• 3+ years developing and delivering regulatory project submissions.
• Experience leading Regulatory Intelligence & Policy activities.

Responsibilities

• Lead the acquisition and analysis of US regulatory intelligence.
• Collaborate with cross-functional teams to inform regulatory strategies.
• Develop and execute regulatory policy and advocacy activities.

Skills

Regulatory strategy development

Leadership in Regulatory Affairs

Knowledge of US FDA regulations

Cross-functional collaboration

Education

Bachelor's degree in medicine or life sciences

Advanced degree (Masters, Pharm.D., Ph.D., MD, JD)

Job description

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary:

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.

Intelligence: The US RIP lead will: 1) Lead the acquisition, analysis, communication, and knowledge management of US regulatory intelligence (RI); 2) Interpret, analyze, and apply US regulatory intelligence to inform strategic decisions of asset teams and leadership, as well as to inform the development of DS policy positions; 3) Lead the strategic development and implementation of an assigned project portfolio (including the development of technology enabled systems, tools, processes, and key performance indicators) for identifying, analysing, and leveraging changes, trends, and other developments in the regulatory landscape, through a global lens, across all key markets where DS operates. The US RIP lead will leverage a wide variety of diverse internal and external sources, databases and networks, to interpret regulatory information into actionable insights that relate to DS's portfolio of development and marketed assets, and synthesize and communicate these findings to relevant cross-functional stakeholders, to help inform future DS regulatory/development strategies, activities and ways of working.

Policy/Advocacy: The US RPI Lead will lead DS regulatory policy and advocacy activities for an assigned portfolio of policy topics. For assigned US issue sets, this role will be responsible for maintaining and efficiently and effectively communicating the current pulse of the issue, developing the DS US position, contributing to the development of Global Regulatory Affairs positions (and potentially serving as both the US and Global GRIP Lead on assigned topics), leading public commenting and other advocacy on assigned topics to ensure that DS has a voice in defining and shaping new or proposed FDA regulatory opportunities/changes/requirements (policy, regulations, guidance, pilots, workshops, etc.), and for preparing DS teams to efficiently navigate these changes to seize opportunities and to mitigate risk. Policy/advocacy activities will include but are not limited to partnering with regulators, interacting and influencing trade associations and other key external stakeholders, securing and executing opportunities to present and publish externally, briefing senior leaders, regulatory affairs teams, and other relevant functions, as well as contributing to the development and execution of assigned global regulatory policy activities. US Focus but with Global Lens/Mindset: While the core responsibilities are US focused, the US Lead will routinely engage with other regional leads and global subject matter experts in regulatory and other DS partner functions to ensure intelligence is analyzed via a global lens and that DS policy development considers the global environment and implications to maximize the impact of intelligence analysis and policy shaping activities. The US Lead may also serve as the global policy lead for specific assigned issues and will contribute to the GRIP CoE's global deliverables. The US Lead will also have a key role in cross-region mentoring and development activities. Stakeholder Engagement: The role will engage internal/external stakeholders from across functions on key regulatory topics, particularly related to biologics/oncology, including coordinating GRIP CoE activities with RA-CMC, R&D & corporate affairs as needed.

Responsibilities:

Regulatory Intelligence (RI)

• Lead the monitoring, collection, synthesis, analysis, communication, archiving, and retrieval of key regulatory intelligence in a systematic manner for the US region, (and for a limited number of global issue sets driven by US FDA regulatory policy).
• Transform regulatory information into actionable insights specific to Daiichi Sankyo, that will facilitate the rapid and efficient development and approval of Daiichi Sankyo medicines.
• Contribute US regulatory intelligence content and perspective into deliverables (e.g., Quarterly GRIP Insight Reports, Ad Hoc GRIP CoE Alerts Notes; Quarterly Global SOP Committee Updates; and other fora as assigned).
• Deliver insightful, proactive (e.g., from routine monitoring of priority issues) and responsive RI and analysis (e.g., in response to internal asset team and GRA Leadership queries), both through a global lens.
• Leverage RI analyses to inform strategic decisions at both asset and above asset levels (e.g., using external/internal precedence, case studies, statements from regulators, etc.).
• Leverage regulatory intelligence to inform the development and successful execution of Daiichi Sankyo regulatory policy goals.
• Develop and maintain strong collaborative networks/relationships with cross-functional subject matter experts (SMEs) and Daiichi Sankyo partner functions that generate, analyze, and consume intelligence.
• Leverage and maintain expert proficiency in the use of internal and commercial third-party RI tools, and mentor others to use.
• Lead the development, implementation, maintenance, and continuous improvement of assigned elements of GRIP infrastructure (e.g., systems, tools, and processes) that enhance the efficiency and impact of the GRIP deliverables and team.
• Contribute to the efficient global operation and continuous improvement of the GRIP CoE (e.g., key performance indicators, team meetings, mentoring, representing the GRIP CoE on cross-functional GRA and intel projects, vendor interactions).

Prioritization:

• Identify and establish a focused set of US Regulatory Policy priorities for external engagement that are aligned with DS functions and leadership, and will have maximum positive impact on patients and accelerating the delivery of the DS portfolio. Horizon scan for emerging US regulatory policy topics; adjust priorities as needed.
• Lead DS regulatory policy and advocacy activities for assigned portfolio of policy topics.
• For assigned issue sets:
• Monitoring Communication: Efficiently and effectively monitor communicate the current pulse of priority issues to Daiichi Sankyo stakeholders via a global lens that includes global context and implications (e.g., briefings to senior leaders, including in advance of trade association interactions). Prepare Daiichi Sankyo teams to efficiently navigate policy/regulatory changes to seize opportunities and to mitigate risk.
• Position Development: Develop US regulatory policy/position papers, in partnership with Daiichi Sankyo subject matter experts, ensuring alignment with key stakeholders internally to ensure a unified voice for subsequent Daiichi Sankyo advocacy. Lead or contribute to development and finalization of DS Global Positions. Potentially serve as both US Global GRIP policy lead on assigned topics.
• Advocacy: Develop and execute strategic advocacy plans to achieve policy-shaping objectives for key policy topics, and grow the positive reputation of DS.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university):

• Bachelor\'s degree in medicine, life sciences, health or related field required
• Advanced degree e.g., Masters, Pharm.D., Ph.D., MD, JD preferred

Experience Qualifications:

• 7 or more years\' experience in biopharma Regulatory Affairs, with at least 3 years developing regulatory strategies incl. successful delivery of regulatory projects submissions, and a working knowledge of US FDA regulations and guidelines regarding drug development, regulatory submissions and corresponding regulatory agency interactions required
• 4 or more years\' experience: 1) Leading and executing Regulatory Intelligence (RI) & Policy activities in the U.S., incl. monitoring, collecting, synthesizing, analyzing, communicating, and managing RI in a systematic retrievable manner for the US region, and 2) Leading and executing US Reg Policy activities, incl. partnering with regulators; coordinating engagement with and influencing trade associations and other key external stakeholders; securing and executing opportunities to present and publish externally; briefing senior leaders, regulatory affairs teams, and other internal relevant functions. Strong experience and working relationships across FDA and PhRMA highly desirable required
• 1 or more years experience working with international teams; strong understanding of cross-cultural environments and different business practices across key markets preferred
• 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 preferred

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range: $189,520.00 - $284,280.00

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