Senior GPRM Japan

Global Program Regulatory Manager (GPRM) Japanの業務には,以下の醍醐味,やりがいがあります.
医薬品や再生医療等製品の初期開発段階からプロジェクトチームに参画し,承認取得までの期間を通し,薬事戦略の立案やそれに基づく開発プランの作成,規制当局(MHLW, PMDA)との折衝,Globalと協働しながら世界同時開発,申請/承認をドライブしていくことに興味のある方,ぜひご応募ください.

- 開発早期から承認取得,市販後まで薬の一生に幅広く関わることができる
- 規制や業界の流れを正しく読み取り,将来的な変化を見越した薬事戦略の立案/実行をリードできる
- 社内外の顧客や海外の開発関連部署など多くのメンバーと多岐にわたる仕事に携われる
- 個人としての作業に加えて,チームメンバーとの協働を通じて,申請•承認などの大きなマイルストーンも経験できる
- 社外の業界活動に参画し規制当局も巻き込み先進的な医薬品開発を推進していく積極的な活動にも貢献できる

備考:NSX&MDPMはコンパニオン診断薬等の開発業務も担っていますが,今回は神経科学•眼科領域(遺伝子治療含む)の薬事担当者の募集となります.

Job Purpose:
 Lead/Contribute drug development* toward obtaining the marketing authorization approval and maintenance activities of post marketing products as Sr. GPRM-J by appropriate regulatory knowledge and actions.Support/assist manager GPRM-J/GPRM-J/Head of RA Unit Japan with extensive knowledge and experiences beyond own therapeutic area for actual/potential issues/risks
 Contribute establishing the position of Novartis Japan in Pharmaceutical industry as "Leading Company"
* Drug development including development of drug, medical device and tissue-engineered medical products

Major Accountabilities:
 For the following activities, lead own products and support/aid manager GPRM-J/GPRM-J for other products to solve complicated issues/problems.
- Developing innovative and high quality regulatory strategies to facilitate regulatory processes in development
- Ensure registration with optimized labels that contribute to health and welfare of the Japanese nation.
- Take regulatory actions to maintain products marketed in Japan.
- Ensure adherence to regulations, guidelines and global/internal procedures as required.
 Establish mutual-trust relationship with the Japanese HAs and obtain high credibility.
 Leadership and direct/indirect involvement in the industry activities to lead the regulatory discussion in complying with Novartis’s wishes.

Why consider Novartis?

817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています.
約10万の社員が世界中のノバルティスで働いており,その国籍は約147カ国に及びます.
ノバルティスファーマ株式会社は,スイス•バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー,ノバルティスの日本法人です.ノバルティスは,より充実したすこやかな毎日のために,これからの医薬品と医療の未来を描いています.詳細はホームページをご覧ください. https://www.novartis.co.jp

Japan
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individuals with disabilities. If, because of a medical condition or disability, you need a
reasonable accommodation for any part of the recruitment process, or in order to
perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact
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す.
健康状態や障害を理由に採用プロセスのいかなる部分においても,あるいは職務の
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い.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education:
 Degree in pharmacy, medicines, science, agriculture and/or pharmaceutical engineering discipline required and advanced degree (Master Degree, PhD, etc.) preferable.
 Pharmacist license preferred.

Languages:
Fluent English as business language

Experience/Professional requirement:
1. 10 years or more experience in pharmaceutical industry, and demonstrate extensive knowledge in drug development/maintenance and global regulatory environment.
2. Possess extensive knowledge of Japanese regulation and enough skills beyond own TA to apply the knowledge into actual product development and maintenance of post marketing product.
3. Integrate scientific issues from a regulatory standpoint across line functions to generate development options.
4. Provide advices to senior management and advocate a course of actions assessing the potential impact of emerging pharmaceutical affairs law, regulations and guidelines affecting Novartis pipeline and portfolio.
5. Possess extensive knowledge of the Japanese HAs management, structures and organizations, and maintain trustful working relationship with the Japanese HAs.
6. Possess extensive scientific knowledge of RA Unit.
7. Coach manager GPRM-J/GPRM-J on drug development.
8. Contribute to discussions on licensing conditions and integrate legal considerations into regulatory strategy.
9. Define internal procedures for complying with effective regulatory requirements and enhancing quality and efficiency of the processes.
10. Effectively negotiate with cross functional teams and lead an agreement in the optimal solution, and manage internal/external negotiation on development strategies and business critical issues.
11. Discuss local regulatory strategies at global level in English.
12. Contribute drug development planning by integrating expertise in the regulatory, legal and business environments.
13. Have the ability to participate in industry group activities as a representative of the Novartis Japan, and ex-press opinions positively and lead the industry's other members.