Senior Director, Global Regulatory Policy – Asia-Pacific, GRA/Senior Director P5

2 months ago

Hong Kong, Central and Western District, Hong Kong SAR China Lilly Full time

Job Summary

Lilly is seeking a Senior Director, Global Regulatory Policy – Asia-Pacific, GRA to lead science-based and efficient global regulatory policy initiatives in the region. The successful candidate will develop Lilly policy positions, assess and engage in external stakeholder groups, and represent Lilly on relevant external work groups to effect and lead policy change in the region and beyond.

Key Responsibilities

  • Support multiple policy campaigns to positively impact regulatory convergence in the Asia-Pacific region and harmonization across both regional and global regulators.
  • Enable Lilly to achieve global regulatory convergence policy advances within the Asia-Pacific region to deliver global simultaneous medicine development, submissions, approvals, and launches.
  • Anticipate, identify, and solve complex policy technical issues affecting the functional, business area, and/or long-term regulatory policy environment.
  • Own the responsibility of developing Lilly policy position papers in coordination with internal and regional subject matter experts.
  • Develop Lilly's input to enhance current and draft regulations, guidelines, free trade agreements, and public consultations.
  • Collaborate cross-functionally to progress regulatory policies supportive of regulatory science and Lilly's innovation strategy.
  • Collect data and/or conduct research to support company policy positions.
  • Perform stakeholder analyses to understand external perspectives on key Lilly policy priorities.
  • Track, monitor, and provide analysis of relevant regulatory policies, as directed by management.
  • Lead the development and implementation of tactical policy plans, including a description of both short- and long-term project deliverables.

Exert External Influence

  • Propose and deliver to regulators and other stakeholders' key messages and communication plans that advance the adoption of Lilly policy positions within the Asia-Pacific region and included countries.
  • Identify long- and short-term regulator, competitive, and environmental trends and effectively communicate implications to internal collaborators, including leadership.
  • Evaluate new regulatory and policy developments and play a direct role in influencing regulations or strategies.
  • Develop relationships with key external stakeholders to understand their perspectives and inform them regarding Lilly's positions.
  • Participate as a member of trade association teams to leverage Lilly positions.
  • Participate as a member and represent Lilly in regulatory policy and regulatory intelligence regional forums.
  • Represent Lilly through engagement in conferences (e.g., APEC GRP, DIA).
  • Positively impact patient outcomes through collaboration across partner groups.

Effectively Lead, Engage, and Partner

  • Model leadership behaviors and regulatory excellence attributes.
  • Demonstrate impact across multiple functions and geographic areas.
  • Communicate best practices broadly across teams.
  • Influence senior management, regulators, and external partners on key regulatory policy decisions.
  • Makes complex technical or business decisions within general functional, company, and industry guidelines.
  • Leads large-scale regulatory policy projects to achieve critical policy shaping objectives.
  • Contribute to forums that share regulatory information across global regulatory components and other Lilly teams and business partners.

Basic Qualifications

  • Bachelor of Science or Bachelor of Arts in relevant policy, public health, regulatory, clinical, legal, business, research, or related field; Masters or doctorate preferred.
  • Five years of prior regulatory and/or regulatory policy experience within a relevant government agency or company.
  • Strong interpersonal skills and demonstrated ability to manage external and internal relationships with key stakeholders.
  • Ability to research and write briefings, positions, and high-level communications.
  • Ability to travel within the region and beyond to attend meetings.
  • Independence, resourcefulness, influence without authority.
  • Strong communication skills, both verbal and written.
  • Fluency in English and other applicable language(s).

Location

  • This position supports hybrid working in Korea, Taiwan, Singapore, Japan, China, or other feasible location within the region.
  • Work authorization
  • 日本での就業は、日本の就業許可を持っていることが応募の条件となります。

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