Regulatory Manager (Specialty)

職務の目的および主な業務内容

Job Purpose & Key Responsibilities

スペシャルティ領域での新薬の承認取得を通して日本の患者さんにイノベイティブな治療を提供することに貢献できる業務です

より難易度の高いプロジェクトや国内外ともにステークホルダーが多いプロジェクトにおいて以下を行う

• 新薬開発及びライフサイクルマネジメントにおいて薬事戦略を立案/実行する
• 薬事関連規制や関連する事例等を考慮した薬事戦略を立案しチームメンバーと協働して実行する
• 承認申請や対面助言等薬事関連業務をリードし規制当局との交渉戦略を立案/実行する
• 薬事的課題を分析し適切な解決策を提案/実行する
• 海外チームと良好な信頼関係を築き薬事関連規制や薬事戦略の提供を実行する
• 海外薬事規制等を踏まえた国内薬事規制の問題点を提示する
• 規制当局と良好な信頼関係を築き適切なコミュニケーションと薬事的交渉を実行する
• 規制当局との交渉の場において議論内容をリードする

職務内容および勤務地の変更範囲は会社の定めるところとする

必要な条件Basic Qualification

スキル Skill

• 薬機法の体系開発承認審査の概略に関する知識
• プロジェクトチームや規制当局で開発薬事戦略を説明するコミュニケーション力
• グローバルコミュニケーション力英語での理論構築読み書き会話力

経験 Experience

• 医薬品等の新薬開発関連業務

学位/資格/語学力 Education/certification/Language

• 医学薬学生物学科学等での学士もしくはそれと同等以上

望ましい条件 Preferred Qualification

スキル Skill

• ロジカルシンキング
• 既成概念にとらわれない思考
• 変化を積極的に受け入れ挑戦し実行する姿勢

経験 Experience

• 医薬品等の新薬承認申請対面助言関連業務

学位/資格/語学力 Education/certification/Language

• 修士博士もしくはそれと同等以上

Skills

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities contact . Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.