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

2 weeks ago

Shanghai, Shanghai, China Lilly Full time

We're looking for people who are determined to make life better for people around the world.

Job Description

At Lilly, 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 Lilly 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 Senior Director, Global Regulatory Policy, Asia-Pacific region is to lead science-based and efficient global regulatory policy initiatives in the region by developing Lilly policy positions, assessing, and engaging in external stakeholder groups, and representing Lilly 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 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 the development of Lilly policy position papers in coordination with internal and regional subject matter experts (i.e., problem statements and desired future state). Developing Lilly'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 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:

TThis 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。

Business title :Sr. Director_ Global Regulatory Policy – Asia-Pacific, GRA

日本就業の場合

【就業場所 Working Location】 神戸本社 Kobe Office 東京支社

従事すべき業務の変更の範囲 :当社業務全般

就業場所の変更の範囲 :将来のキャリアの一環として、神戸本社・東京支社・西神工場・ 海外オフィスでの勤務をする場合もありうる

日本での就業の場合の処遇となります。(就業の国毎に異なることはご理解ください。)

【給与】当社規定により優遇します

【諸手当】住宅手当、通勤交通費など

【昇給】有り

【賞与】年一回 個人業績結果及び会社業績結果に基づく業績変動賞与を翌年3月に支給する。

【勤務時間】8:45~17:30

【時間外手当】"担当職"のみ支給

【清算制フレックス勤務】適応あり。フレキシブルタイム:5時~22時内で勤務。(ただし、一斉休憩を除く)1日の必要最低労

働時間:4時間(半日休暇時は2時間)一斉休憩:12時~13時

【在宅勤務制度】有

【受動喫煙対策】あり 就業場所 全面禁煙

【休日休暇】完全週休2日制(土・日曜日)、祝日、年末年始・夏期

*年間休日125日、年次有給休暇、慶弔等

【保険】雇用・労災・健康・厚生年金保険

【福利厚生】住宅援助制度、借上社宅制度、リリーグループ補償制度(医療費・歯科医療費補助制度等)

【定年制】有(60歳)

【継続雇用制度】:有(65歳まで)

【有給休暇】

年途中で入社した社員に対する年次有給休暇は、次の入社月の区分に従い入社の翌月1日に付与さる。入社日にかかわらず、その年の12月31日をもって、勤続年数が1年経過したものとみなし、翌年1月1日に翌年度の年次有給休暇が付与される。

入社月 1-6月 7月 8月 9月 10月 11月 1 2月

付与日数

【試用期間】 6か月間 試用期間中での賃金の違いはございません

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

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