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Head Regulatory Affairs Consumer Health Care (CHC) Japan  /  非公開

ジョブNo.NJB2041195
職種 Head Regulatory Affairs Consumer Health Care (CHC) Japan
社名 非公開
業務内容 Purpose of the role:

The Regulatory Affairs CHC Japan Head is responsible for leading the local CHC Regulatory team ensuring compliance of the existing CHC portfolio effective and timely approval of all marketing authorizations maintenance provide appropriate input on the development of new products and shape the regulatory environment. She/he will be a full member of the Country CHC Leadership team and CHC Regional Regulatory Leadership team

The business growth ambition is to be the fastest growing CHC business in Japan outperforming the market. Success will be achieved through:

Embedding best in class capabilities which will put regulatory Japan at the heart of our success
Driving transformation focused on excellence in execution adopting innovative approaches simplification including optimization of processes and embracing digital as part of the strategic roadmap
Building the ability to understand both scientific and commercial aspects of our category/brand strategies and work in partnership and collaboration with cross functional colleagues to help shape and deliver the growth model.
Creation of a dynamic CHC mindset driven culture that empowers individuals to deliver business priorities
求める経験 ■Education and Experience:
Minimum MS; Pharm D MD PhD or equivalent preferred
Minimum 7 10 years in Regulatory Affairs including leadership roles and experience in more than one country or region.
Expert in working in matrix teams
Demonstrated ability to independently lead motivate and develop teams and implement operational regulatory excellence
Demonstrated success in developing regulatory strategies in OTC environments including Rx to OTC switches; possesses a strong knowledge of the switch scheme and the regulatory requirements across any regulatory application classification
Experience in shaping the regulatory environment through active lead in trade associations

■Special Knowledge Qualifications
Excellent understanding of the consumer healthcare and pharmaceutical industry drug development environment and R D processes and objectives
Expert knowledge of consumer healthcare regulations and requirements HA regulations and ability to evaluate impact of those regulations within the drug development environment and to lead discussions of the requirements and its impacts within submission teams
Fluent spoken and written English (at least a TOIEC score of 700)
Competencies

Lead teams
Develop people
Act for Change
Cooperate Transversally
Strive for Results
Commitment to Customer
Think Strategically
Make Decisions
Additional Skills

Strong interpersonal/communication negotiation and influencing skills. Ability to develop strong networks and influence internal and external stakeholders
Business acumen and customer orientation. Drive creative innovative ideas to support the business.
At ease working in a matrix environment and displays the necessary multicultural sensitivity in a Global environment
High standards of integrity
語学力 英語力:上級
勤務地
東京都
年収 1500万円 - 2800万円
雇用形態 無期雇用

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