仕事内容【Job Description】
At company, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
【Organization Overview】
Global Regulatory Policy and Strategy (GRPS) enables company to deliver innovative regulatory results by identifying policy hurdles and emerging trends, developing advocacy plans built upon science-based positions, engaging broad partner networks, and ultimately effecting change in regulatory policies that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of the Associate Director, Global Regulatory Policy, Asia-Pacific region is to support science-based and efficient global regulatory policy initiatives in the region by developing company policy positions, assessing, and engaging in external stakeholder groups, and representing company on relevant external work groups with the goal of effecting and leading policy change in the region and beyond.
【Responsibilities】
●Support Multiple Policy Campaigns
Primary geographies of regulatory policy responsibility for this position will be Korea, Taiwan, Singapore, Australia, and coordination with Japan and China regulatory policy colleagues.
Primary responsibility will be to enhance regulatory convergence in the Asia-Pacific region and harmonization across both regional and global regulators.
Enable company to advance global regulatory convergence within the Asia-Pacific region to deliver global simultaneous medicine development, submissions, approvals, and launches.
Support the development of company policy position papers in coordination with internal and regional subject matter experts (i.e., problem statements and desired future state).
Develop and/or coordinate company’s input to enhance current and draft regulations, guidelines, free trade agreements, and public consultations.
Collaborate cross-functionally (e.g., corporate affairs, legal, safety) to progress regulatory policies supportive of regulatory science and company’s innovation strategy.
Collect data and/or conduct research to support company policy positions.
Perform stakeholder analyses to understand external perspectives on key company policy priorities.
Track, monitor, and provide analysis of relevant regulatory policies, as directed by management.
Monitor the external environment for new regulatory and policy developments and possible implications on company’s positions and communicate with internal stakeholders.
Support the development and implementation of tactical policy plans, including a description of both short- and long-term project deliverables.
●Exert External Influence
Propose key messages and communication plans that advance the adoption of company policy positions within the Asia-Pacific region and included countries.
Develop relationships with key external stakeholders to understand their perspectives and inform them regarding company’s positions.
Participate as a member of trade association teams to leverage company positions.
Participate as a member and represent company in regulatory policy and regulatory intelligence regional forums.
Represent company 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.
Engage in forums that share regulatory information across global regulatory componentsand other company teams and business partners.
経験・資格【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.
・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)
・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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政府系 金融機関 投資部門 クレジット投資及びオルタナティブ投資担当
多くの人が待ち望み、誰も作れなかった新薬を高度な技術で生産し、世界市場に届けます。
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「ODMメーカー」として、業界の中で独自の事業展開をしていこうとしています。
真摯で熱い気持ちを持ったメンバーが揃っている会社です
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