糖尿病、オンコロジー、血栓症、循環器疾患、内科系疾患、希少疾患の各主要領域における新製品の開発や主力製品の剤形・適応追加に取り組んむグローバルファーマ

【業務内容】Provide leadership, working collaboratively with both internal and external stakeholders, to advance Regulatory Science and strategically influence the policy environment set by regulatory authorities in JPAC region.
Responsibility:Guide development of policy positions for external influence and for internal product development (as needed). Cooperatively create and execute advocacy strategies to achieve policy goals.

○Develop effective and systematic approaches to bring functional excellence to Regulatory Policy across group in JPAC with emphasis on key markets. Drive best practices and excellence in execution within the department and cross-functionally.
○Work closely and partner with a number of subject matter experts to plan regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest (influence regulatory authorities in the development and implementation of emerging regulatory policy).
○Proactively participate and track key developments from health authorities, trade associations, special interest groups, industry thought leaders and other external parties that are relevant to regulatory activities at industry at large. Communicate regarding specific regulatory trends, analysis, policies and Intelligence to different functions. Guide the strategy to understand and mitigate impact.
○Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment on position.
○Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may bear influence to propose action plan.

【必須】
Advance life science degree.
+10 years experience in the field and/or related areas. Extensive and proven expertise in Regulatory environment in healthcare.
Existing relationship with local/regional government legislators, committees, administrative staff or other key parties or influencers.
Strong influencing and negotiation skills.
English and Japanese : Fluent or Advanced Business Level

【Plus】
Previous experience working with senior-level members or officials of trade associations or other key groups that influence regional policies.
Experience in participating in, or supporting, global product development or other cross-functional teams.
Outstanding interpersonal and communication/presentation skills.

【勤務地】 都内

【年収】1200～1600万円・応相談
【給与・賞与】経験・能力を考慮の上、当社規定により算出します
【諸手当】通勤手当、住宅手当、等
【昇給・賞与】昇給 年１回、賞与 年１回
【休日・休暇】完全週休２日制（土・日）、祝日、年末年始（12/29～1/4）、フレキシブル休日、5/１、年次有給休暇、慶弔休暇 他
【福利厚生】各種社会保険完備、社宅制度、退職金制度、財形貯蓄制度、共済会　等

【選考】二次選考、英語面接となります
【募集部署】薬事薬制本部　レギュラトリーインテリジェンス室