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Location

New Jersey | United States

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Job description

Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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 responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line management, to identify and lead global corporate initiatives, ensuring that DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in defining new requirements. The role will be responsible for coordinating a global team of representatives across all major regions, incl. direct reports for the US, EU and China, and indirect accountability for JP representatives.

As part of leading Regulatory Intelligence, this role will lead the development and implementation of a global approach (incl. processes, roles & responsibilities, systems and tools) for identifying and analysing key trends, changes and any other developments in the regulatory landscape across all key markets where DS operates. The individual in this role will oversee the consistent collection of regulatory intelligence from all regional team members via a range of sources and databases and support/coordinate the team to interpret this information into actionable insights, as they 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.

This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and approach to engage with trade associations, regulators and other relevant industry stakeholders on key regulatory topics both globally and regionally, to maximize the impact of policy-shaping activities. This includes supporting the regional reps to build and leverage a network of relationships with external stakeholders and regulatory authorities to ensure DS' perspective is reflected in the creation of future policy, regulation and guidelines, and collaborating with key functional leaders to define DS's unified position and external engagement strategy on key topics. This role will also define and implement a process to respond to draft policy/guidance proposals. This role will engage with a range of internal and external stakeholders from across functions on key regulatory topics, particularly relating to biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory-CMC function and corporate affairs as needed. In the short term, the individual in this role will also act as the US Reg Intel & Policy regional representative, directly responsible for Reg Intel & Policy activities focused on the USA, alongside coordinating the global team.

Responsibilities

Lead and manage a global regulatory intelligence and policy team

• Leads day-to-day a team of Regulatory Intelligence Policy professionals across all major regions, incl. mentorship, performance mgmt., etc.
• Supports the team in both Regulatory Intelligence (collection, interpretation and communication) and Policy (policy position development, coordination of SMEs, external engagement) activities, while maintaining consistency in approaches across regions
• Manages resourcing and workload across the team
• Acts as the single point of accountability for Regulatory Intelligence and Policy activities, incl. the point of escalation for internal disagreements relating to Intel/Policy activities
• Has a strong understanding and experience of intercultural norms and ways of working

Regulatory Intelligence

• Develop and implement a process (incl. overseeing associated tools) for global intelligence gathering that also accounts for nuances between different world regions and addresses regional regulatory needs and priorities (e.g. through collaboration with regional RA leads and teams)
• Support regional representatives in collecting, analyzing, and synthesizing key regulatory intelligence in a systematic manner
• Establishes a database and/or process for maintaining the database and incorporating DS’ perspective to augment the database as DS gains experience particularly in areas like ADCs where others may be less advanced
• Support and oversee the preparation of communications to stakeholders of all levels through various modes of communication including reports, educational summaries, trainings, to keep key DS experts and teams up to date on the latest developments in regulatory science
• Defines, implements and oversees/coordinates the process to liaise with broader SMEs to evaluate draft HA guidance and coordinate DS’ response/comments to these, to help curate future regulatory guidance that is compatible with DS' strategic objectives
• Work with other DS functions (incl. Regulatory-CMC) to coordinate Regulatory Intelligence activities and ensure regulatory/development strategies take into account upcoming regulatory changes
• In the short term, act as the US Reg Intel lead, responsible for collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework.

Regulatory Policy

• Scans the horizon for upcoming regulatory policy topics across all key markets and aligns within DS functions on where DS should prioritize external engagement efforts for maximum impact
• Defines a global strategy for achieving policy-shaping objectives (e.g. via trade association, in partnership with other pharma outside of trade associations, or standalone as a company)
• Develops policies/position papers and aligns with key stakeholders internally to ensure a unified voice for Daiichi Sankyo to drive policy shaping initiatives, and disseminates to relevant stakeholder groups
• Tracks the impact and reports cross-functionally on policy-shaping activities
• Engages with key external stakeholders including regulators and trade associations to share DS' perspective on relevant issues;
• Joins and represents DS at trade association meetings, and reports back key insights to the GRA Leadership Team and others relevant stakeholders
• Partners with cross-functional leaders incl. from across RD, Safety, Tech/Supply and Commercial to coordinate SMEs and engagement activities with trade associations and other industry groups on key topics
• In the short term, act as the US Reg Policy Lead, responsible for tactically coordinating engagement with US regulatory bodies and trade associations, incl. PhRMA.

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 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 pharma Regulatory Affairs, with at least 3 years developing regulatory strategies incl. successful delivery of regulatory projects submissions, and a working knowledge of global regulations and guidelines regarding drug development (incl. CMC), regulatory submissions and corresponding regulatory agency interactions globally
• 4 or More Years Experience in coordinating Regulatory Intelligence & Policy activities in one or more regions (USA required), incl. maintaining a database of regulatory intelligence and coordinating engagement with industry trade associates and regulators on policy shaping activities; strong working relationships across FDA required, EMA, PMDA and NMPA experience highly desirable
• 4 or More Years Leadership experience, working with and leading international teams; strong understanding of cross-cultural environments and different business practices across key markets
• 1 or More Years of Experience of working with the global regulatory landscape for at least 2 of the following: •Oncology drugs •Biologics/ADCs •Medical devices •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.

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