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〈研究開発・メディカルアフェアーズ統括本部〉薬事部 開発薬事/担当・担当課長・専門課長/神戸

Kobe, Japan

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Req ID R-14309 Title 〈研究開発・メディカルアフェアーズ統括本部〉薬事部 開発薬事/担当・担当課長・専門課長/神戸 City Kobe City State / Province Hyogo Country Japan Region Research

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

開発薬事担当者(Regulatory Scientist)としての主な役割

  • 担当する医療用医薬品/医療機器(以下、担当品目)の日本における開発において、薬事Strategy&Planを策定・実行し、製造販売承認を取得します
  • 担当品目の薬事Strategy&Planを社内Project team (Japan & Global)メンバーやシニアマネージメントに適切に説明し、効果的に規制当局(PMDA / MHLW)と交渉します
  • 薬事部の組織としての能力および生産性向上について、Regulatory policyやScientific knowledge / Intelligenceを共有することで貢献します

主要な責任範囲

  • Ownership及びAccountability(説明責任)をもって、担当品目の期待される薬事的成果を達成するよう努めます
  • 開発薬事担当者(Regulatory representative)として、担当品目の薬事Strategy&Plan(リスク評価を含む)を策定し、Project teamと協働してその実行をリードし、規制当局より製造販売承認を取得します
  • 担当品目の開発薬事関連事項全般について、規制当局(PMDA / MHLW)と効果的にコミュニケーション及び交渉を行います
  • 規制当局(PMDA / MHLW)の担当者と信頼関係を確立・維持します
  • 日本語での薬事文書の作成、校閲を適切に行います
  • Global薬事担当者と良好な協力関係を確立・維持します
  • 薬事情報や規制当局(PMDA / MHLW)の考えを積極的にProject team (Japan & Global)メンバーにインプットし、意思決定に影響を与えます

Business Title: Associate /Sr Associate / Reg Scientist-TA Reg Dia/Onc

<必須経験/スキル・資格 Minimum qualification requirements>

必要な知識、スキル

  • 日本における製薬関連規制の知識 (新医薬品の開発~承認取得の知識があればより良い)
  • 効果的なコミュニケーション及び交渉のスキル(日本語は母国語、英語はビジネスレベルTOEIC 650以上)
  • 論理的/戦略的な思考スキル

必要な資格、経験

  • 薬学または科学分野の4年制大学の学位
  • 薬事、臨床開発を含む医薬品研究開発関連部門、規制当局(PMDA / MHLW)担当者、いずれかの業務経験
    (新薬開発~承認取得における規制当局(PMDA / MHLW)との対応経験があれば、より良い)

Job Responsibilities

As a Regulatory Scientist of TA regulatory, followings are expected role.

  • Create regulatory strategy & plan for responsible products to ensure drug / device development in Japan and to obtain regulatory approval.
  • Explain regulatory strategy & plan logically to internal and external key stakeholders including global team and PMDA/MHLW for relevant products.
  • Contribute to functional capability and productivity development through providing regulatory policy and scientific knowledge to other members in regulatory group.

Primary responsibilities

  • Ownership and accountability in delivering regulatory outcomes in relevant products.
  • As a regulatory representative in the product team, create regulatory strategy & plan, and lead its implementation for Japan regulatory approvals.
  • Communicate/negotiate with PMDA and MHLW effectively on all regulatory matters for relevant products.
  • Establish and maintain good relationship with regulators in PMDA/MHLW.
  • Writing and reviewing Japanese regulatory documents.
  • Establish a collaborative working relationship with global regulatory affairs colleagues.
  • Influence to relevant product team members to raise the awareness on the regulatory trend.

<Minimum qualification requirements>

Knowledge & Skills Desirable to Perform Role

  • Knowledge of pharmaceutical regulations in Japan (Knowledge on the process from new drug development through MHLW approval acquisition - even better)
  • Knowledge of drug development in Japan
  • Effective communication and negotiation skills in both Japanese (Native language level) and English (business level; TOEIC 650 or above)
  • Logical / strategic thinking skills

Qualification: Education & Work Experience Desirable to Perform Role

  • Four (4) years’ university degree in scientific field
  • Work experience in regulatory affairs or other R&D functions (including Clinical development), or as an officer in the regulatory authorities(PMDA/MHLW)
  • Experience in interacting and negotiating with PMDA/MHLW is  mor desirable

<処遇>

【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  12月

付与日数  10   5   4   3    2    1   0

【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

Eli Lilly Japan社員の方へ、

社内公募へ自ら応募して異動/転勤する場合のサポート内容はビジネスニーズに基づき異動/転勤する場合と異なりますので、

あらかじめ応募にあたっては、詳細は以下リンク先にある情報をご確認とご理解を頂くようお願いいたします。

https://now.lilly.com/landingoverview/JP-change-in-career-system/JP-changes-in-my-career-faqs

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-14309.

Lilly is an EEO/Affirmative Action Employer and 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.

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