薬事（全て）の求人一覧

プロジェクトの規制戦略を開発および実施する責任を負う

仕事内容

The manager of RRL JP CMC has responsibility to develop and implement regulatory strategy for the assigned products/projects as LRL, and exercises activities which include:

1) An integral member of the Regulatory Excellence Team, contact point of GRLs for CMC related matters, and contributes to the delivery of robust regulatory strategies and coordination of local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.
2) Interface ＆ contact partner for the Japanese regulatory authorities for development products including those undergoing PMDA Consultation as well as marketed products, Global RA and other cross-functional stakeholders for product and project related regulatory activities for CMC related matters (including Master File).
3) Regulatory expert for the regulatory requirements for CMC matters in Japan.

・Support Head of CMC RA regarding specific projects and activities.
・Act as LRL and/or contact point of GRLs for assigned projects/products, registration submissions and Regulatory Compliance, and be a trusted partner to health authorities as well as .

Accountabilities
1. Regulatory Strategy and Registration Activities
1.1 An integral member of the Regulatory Excellence Team, contact point of GRLs for CMC and Regulatory Compliance related matters, and contributes to the delivery of robust regulatory strategies and coordination of local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.
a. Actively participate in Regulatory Excellence Team meetings and discussions, providing GRL with Japanese regulatory advice and updates. Supports GRL with the local aspects for the generation of Regulatory Status Updates, management briefings (Product Update Reports) as well as pre-reads and presentation at the Regulatory Expert Group (REG).
b. Provide Japanese CMC regulatory input and guidance, ensures local requirements and agreed strategy are addressed in the submissions including expedited regulatory pathways if available
c. Identify, investigate and recommend solutions to potential CMC regulatory challenges during product lifecycle including product defense ＆ benefit / risk assessments.
d. Coordinate, plan and conduct formal / informal meetings and teleconferences with regulatory authorities in Japan in cooperation with GRL and relevant stakeholders as appropriate. (CMC matters).
This includes the lead of preparation of the relevant briefing packages in cooperation with GRL and required stakeholders.
e. Provide guidance and contribute to the strategy and content of local labels for original submissions and product lifecycle management as appropriate. (CMC matters)
f. Deliver robust CMC regulatory strategies for the Japanese regulatory documentation (e.g. Clinical Trial Notifications, local dossier elements for Marketing Authorization Applications and life cycle management).
Generate, provide and manage the application form (FD format) for all types of submissions including Master File.
g. Lead the provision of responses to local Health Authority questions from Japan. Contribute to response strategy in cooperation with GRL and other stakeholders. Submit responses to the Japanese health authority questions. (CMC matters).
h. Support timely submissions to the Japanese regulatory authorities in accordance with the defined submission plans in collaboration with GRL and RA sub team and other stakeholders. (CMC matters).

1.2 Interface ＆ contact partner for the Japanese regulatory authorities for development products including those undergoing PMDA Consultation as well as marketed products, Global RA and other cross functional stakeholders for product and project related regulatory activities for CMC matters:
a. Contact partner for GRA functions on regulatory requirements for Japan and their interpretation for product and project related regulatory activities for the assigned projects/products.
b. Ensure outcome of important agency meetings / regulatory procedures are communicated to GRL and other relevant stakeholders, as appropriate. (CMC matters).
c. Provides regulatory input for Japan to Regional Clinical Development as appropriate and in alignment with the global regulatory strategy and the GRL. (CMC Matters).

1.3 Completion of new labeling for product launches and revisions for product maintenance, efficiently and accurately. (CMC Matters)
- Management of Launch, change and discontinuation of products through the corporate system Go-Track/SLCI/CPD3.

1.4 Act as contact point of GRLs for CMC, related matters, member of Regulatory Excellence Team (RRL JP CMC or LRL) for assigned products/projects, where applicable.

応募条件

【必須事項】

Minimum Education/Degree Requirements
・Bachelor degree in Pharmacy, life sciences, chemistry, or significant practical experience related to CMC.
・Further degrees, e.g. Specialized Pharmacist or Master of Drug Regulatory Affairs are appreciated.

Required Capabilities (Skills, Experience, Competencies)
Knowledge:
・In depth knowledge of international regulatory requirements, including understanding, interpretation and application of the regulatory legislation in Japan.
・Excellent knowledge of and adherence to relevant internal processes and procedures.
・Good knowledge and understanding of regulatory activities associated with all types of drug development, registration and maintenance of approval drug products.
・Good knowledge and experience with managing licenses for marketing authorization holder, manufacturing authorization and wholesaler.
・Good understanding of labeling on packaging.
・Good knowledge and experience with drug development, marketing authorization applications and maintenance of marketing authorizations.
・Good understanding of chemical-pharmaceutical, medical subjects as well as of pharmacovigilance and labeling requirements.
・Well understanding of environment and trend of health authority.

Professional skills:
・Capable to provide the leadership to develop and implement solutions to complex problems.
・Unbiased international view and inter-cultural competence.
・Open minded, motivating personality with drive and initiative.
・Willingness and ability to create and share knowledge.
・Critical thinker with ability to self-manage workload, including reprioritizing and delivery under tight timelines.
・Ability to work well under pressure, influence without authority, good interpersonal and negotiation skills.
・Team player, flexible and willingness to adapt in a changing environment.
・Excellent oral and written communications skills.

Experience:
・More than 3 years’ experience in RA including new drug registration.
・More than 3 years’ experience in R＆D and/or Medical development.
・Practical experience in handling new developments, registrations and maintenance of Marketing authorizations.
・Experience with direct Health Authority interactions.
・Preferably international work experience.

Language skills:
・Japanese: Fluent
・English: Excellent in communicating in English

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】東京

年収・給与

800万円～1150万円　

・輸入電子医療機器（人工呼吸器、手術・検査用機器等）の薬事申請。

仕事内容

医療機器の薬事申請業務
・医療機器等の薬事申請（承認、認証、届出）と維持管理に関する業務
-申請方針の検討・立案
-資料の収集（海外製造元とのコレポン）
-申請書作成
-照会対応
・QMS適合性検査、各種監査への対応
・自社及びメーカーの各種業態の取得・維持に係る申請手続き
・薬事関連情報の収集、管理および社内通達

応募条件

【必須事項】

・医療業界での就業経験
・英語スキル
いずれも満たしている方

【歓迎経験】

クラス3での薬事申請実務経験

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】埼玉

年収・給与

400万円～700万円　

製薬メーカーにて製品開発・品質管理や承認申請書などの書類作成に携わっていただきます。

仕事内容

・製造販売承認、承認申請届け出など書類作成
・品質管理
・製品開発

応募条件

【必須事項】

・大学卒以上
・薬剤師資格

【歓迎経験】

・医薬品の製造販売に係る管理業務経験

【免許・資格】

・薬剤師

【勤務開始日】

応相談

勤務地

【住所】富山

年収・給与

400万円～450万円　経験により応相談

大手製薬メーカーにて新薬開発の進展に伴う薬制薬事業務

仕事内容

募集背景：
医薬品、医療機器、再生医療等製品等の開発の増加・進展に伴い、国内外の薬制薬事業務の増大および薬事規制・薬事動向の変化に対応するため、国内外の薬制薬事に精通した専門性のある方を募集する。

職務内容：
・許可等業者の法令遵守体制の維持・管理（手順書作成・運用、会議体事務局、GQP/GVP部門との連携等）
・国内および海外子会社における製品リスク（回収、偽造医薬品等）への対応
・医薬品（再生医療等製品等新規モダリティ含む）及び医療機器の開発・上市に向けた薬事規制に関連する調査、社内連携のリード
・社内における薬機法等の薬事規制に関する疑義照会対応業務
・海外での医薬品販売承認維持のための薬制業務及びプロジェクトマネジメント業務
・国内外の規制当局との授受文書の管理業務
・国内及び海外当局等から発出される各種薬事規制の収集・分析・社内への適用推進業務
・GMP/QMS/GCTP適合性調査（承認前調査/定期調査）、外国製造業者認定の維持・管理業務
・製造委託先への製造・試験法に関する調査等（承認書と製造実態の整合性に係る年次点検、日局改正対応状況の確認等）

応募条件

【必須事項】

求める経験：
・製薬業界での経験、薬学/理工系大学卒以上
・製薬業、医療機器業における薬制・薬事業務の経験

求めるスキル・知識・能力：
薬機法全般に関する体系的知識
国内における新薬・一変申請、GMP/QMS関連規制に関する知識
＜歓迎要件＞
・海外における医薬品の承認申請の経験
・製造ま　たは品質管理等の経験
・プロジェクトリードまたはマネジメントスキル

求める行動特性：
・周囲との信頼関係の構築
・誠実さ

求める資格：
海外との交信を行う英語力

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】東京

年収・給与

600万円～1100万円　経験により応相談

海外開発おける医療機器薬事として申請業務や海外当局対応

仕事内容

・米国・欧州臨床試験のIDE・IND・CTA申請とその後の米国・欧州申請作業
・米国・欧州薬事コンサル等との協業
・国内基準と米国・欧州基準の米国・欧州コンサル等との協業分析（Gap Analysis）と対策立案
・CRO等との申請作業の協業
・米国・欧州規制当局FDA・EMAとのコンタクトの調整または支援

応募条件

【必須事項】

・大卒以上
・製薬会社・医療機器メーカー、CROまたはPMDA・厚労省・FDA・EMA等の日米欧規制当局における米国薬事の実務経験2年以上、またはその知識がある方
・英語でのコミュニケーション能力（メールでのやり取り、Web・リアル面談ができる）

【歓迎経験】

・製薬会社・医療機器メーカーまたはCROにおいて、欧米当局との薬事経験、IDE・IND・CTA申請、NDA・PMA・de novo申請の経験者

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】在宅可、東京

年収・給与

600万円～1000万円