Head of RA

• Japan Leadership Teamの主要メンバーとして事業および組織運営に関する意思決定に薬事面から貢献し事業成果および組織目標の達成を支援する
• 国内関連法規に基づき総括製造販売責任者Sokatsuとしての責務を遂行する
• 日本市場における薬事戦略の立案実行を主導し法令遵守適切なリスクマネジメントおよび円滑な承認取得を推進する
• ライセンス維持管理安全管理体制の監督を含む薬事オペレーション全般を統括し製品の安全性および規制遵守を確保する
• 国内外の関係部門と連携し日本特有の規制要件に関する理解促進および薬事戦略と事業戦略の整合を図る
• Regulatory AffairsQualityおよびVigilance機能をリードし人材育成コーチング組織能力向上を推進する
• 戦略立案に加え日常の薬事オペレーションにも主体的に関与し事業ニーズに対応する

• 日本法人の経営陣に対し薬事戦略に関する専門的な助言を提供する
• プロジェクト目標の達成に責任を持ち事業戦略と薬事戦略の整合を図るとともに日常の薬事業務にも主体的に関与し事業ニーズに対応する
• 日本市場における薬事戦略の策定および実行を主導し承認取得の実現可能性規制要件スケジュールなどについて積極的な提言を行う
• 日々の薬事オペレーションにも主体的に関与し事業ニーズへの対応を推進する
• 総括製造販売責任者として関連法規に基づく責務を遂行する
• 新規承認申請や変更申請等を含む各種薬事申請業務を統括し規制当局との折衝照会対応を通じて事業目標達成を支援する
• 製品ライフサイクルを通じて変更管理許認可維持添付文書表示改訂等を適切に実施し承認品目のコンプライアンスを維持する
• 製品ライフサイクル全体を通じて発生し得る規制上の課題やリスクを予測し関係部門と連携して解決策を導く
• 製品表示を含む販促資材非販促資材を審査承認し法規制業界ルールおよび社内方針への適合を確保する
• 承認申請や変更内容の進捗状況を国内外の関係者へ適時共有する
• 製品ラベルの評価および改訂対応を行い規制遵守を前提に競争力のある表示内容および迅速な上市を実現する
• 薬事文書関連記録およびRIMS等のデータベースを適切に維持管理する
• 必要な事業許可輸入許可の維持管理を行う
• グローバルポリシーと国内規制要件の差異を補完するためSOP作業手順書WIおよび関連プロセスを整備運用する
• グローバル薬事部門の必須SOPおよびトレーニングの国内展開を推進する
• 規制動向法改正業界動向競合情報等を継続的に把握し適切な薬事戦略へ反映する
• 新製品導入に際して関連部門と連携し上市を支援する
• PMDA厚生労働省東京都庁コンサルタント販売代理店等との良好な関係構築維持を行う
• 規制当局や認証機関による監査査察対応を支援する
• 市販後対応業務を必要に応じて支援する

• 企業のコンプライアンスプログラムを統括しグローバルガイドラインおよび国内法規制への遵守を推進する
• 高い倫理観とコンプライアンス意識を根付かせる企業文化の醸成をリードする
• 医療従事者HCPとの関係性に関する社内基準および関連法令の遵守状況をモニタリングし適切な運用を維持する

• グローバルSOP委託先契約および国内規制要件に準拠した安全管理体制が適切に運用されていることを監督する
• 安全管理に関する国内SOPおよび関連文書の承認を行う
• 安全管理責任者の副担当として24時間365日の安全情報対応体制の維持を支援する
• 安全管理監査査察への対応体制を整備し監査査察時の主要窓口を補佐する

• Regulatory AffairsQualityおよびVigilanceチームのマネジメント人材育成コーチングおよびモチベーション向上を担う
• 関連部門との円滑な協業関係を構築維持する
• 必要に応じて業界団体や専門委員会において会社代表として活動する
• 商標管理や貿易コンプライアンス関連事項について本社と連携する
• コンプライアンス逸脱事象についてCAPA是正予防措置の策定実施を管理し完了まで監督する
• 関連法令Galderma Code of Ethics社内規程およびSOPを遵守する

• 学士号以上薬学生命科学工学または関連分野
• 日本国内の薬剤師資格保有者は歓迎

• 医療機器製薬業界のいずれかにおける薬事業務経験10年以上
• 医療機器領域における薬事戦略立案承認申請ライフサイクルマネジメントの経験
• グローバル企業またはマトリクス組織での勤務経験
• 日本における医療機器医薬品に関する薬事規制および承認制度に関する知識
• 新製品の承認申請から承認取得までを主導した経験
• 厚生労働省MHLWPMDA東京都庁TMG等の規制当局との折衝経験
• QMSを含む品質安全管理に関する知識および関連部門との協働経験
  少人数組織におけるマネジメント経験

• 化粧品業界での経験
• 美容医療皮膚科学医療機器領域での経験

• 英語および日本語読み書き会話ともにビジネスレベル以上

• ヘルスケア業界とりわけコンシューマーヘルス領域の商業的視点を理解し事業ニーズを踏まえた助言ができること
• 高い分析力と課題解決力を有し適切な優先順位とスピード感を持って対応できること
• 優れたコミュニケーション能力とステークホルダーマネジメント能力
• プロジェクトマネジメント問題解決プレゼンテーション交渉タイムマネジメント能力
• 自律的に行動しながらチームでも成果を発揮できること
• 事業上の要請とコンプライアンス要件のバランスを適切に判断できること
• 規制課題に対して戦略的かつ革新的な視点で解決策を導けること
• 業務プロセスおよび組織パフォーマンスの継続的改善に取り組めること
• 主体性を持って組織に貢献し生産性の高い職場環境づくりを推進できること
• 高い実行力を持ち成果創出にコミットできること
• 高い倫理観と信頼性を備えていること
• 戦略的視点と実務遂行力の両方を兼ね備え自ら手を動かしながら組織をリードできること
• QMSおよび日本の規制要件について事業部門や関連部門に対して分かりやすく説明浸透できること
• 多様なステークホルダーとの信頼関係を構築し組織横断的に協働できること
• オープンで透明性の高いコミュニケーションを実践できること
• 変化の速い環境において柔軟かつ主体的に課題解決に取り組めること

Strong regulatory leadership is required to navigate Japans complex and evolving regulatory environment. This role is responsible for driving and executing regulatory strategies supporting day-to-day regulatory operations collaborating across functions and leading organizational development to support business objectives in Japan.
The successful candidate will bring extensive regulatory affairs experience particularly within the medical device sector together with solid knowledge of Quality Management Systems (QMS) experience interacting with Japanese regulatory authorities and the ability to provide both strategic leadership and hands-on execution.

• Serve as a key member of the Japan Leadership Team contributing regulatory expertise to business and organizational decision-making and supporting the achievement of business and people objectives.
• Fulfill the responsibilities of the Marketing Authorization Holder General Manager (Sokatsu) the legally designated regulatory responsible person in Japan in accordance with applicable local regulations.
• Lead the development and execution of regulatory strategies in Japan ensuring regulatory compliance appropriate risk management and successful product registrations.
• Oversee all regulatory operations including license maintenance and vigilance system oversight to ensure product safety and regulatory compliance.
• Partner with local and global stakeholders to promote understanding of Japan-specific regulatory requirements and align regulatory strategies with business priorities.
• Lead and develop the Regulatory Affairs Quality and Vigilance functions through people development coaching and organizational capability building.
  Remain actively involved in day-to-day regulatory activities while providing strategic leadership to support business needs.

• Provide strategic regulatory advice and guidance to the Japan leadership team.
• Take accountability for delivering project objectives by aligning regulatory strategies with business priorities while remaining actively involved in operational activities.
• Lead the development and execution of regulatory strategies in Japan and provide proactive recommendations regarding regulatory requirements timelines and feasibility.
• Actively support day-to-day regulatory operations to meet business needs.
• Perform Sokatsu responsibilities in accordance with applicable local regulations.
• Lead regulatory submissions including new registrations and change applications and manage interactions with health authorities to support business objectives.
• Ensure ongoing compliance of marketed products through lifecycle management activities including change control license maintenance and labeling updates.
• Proactively identify regulatory risks and challenges throughout the product lifecycle and work cross-functionally to develop effective solutions.
  Review and approve promotional and non-promotional materials including product labeling to ensure compliance with local regulations industry codes and company policies.
• Communicate the status of regulatory applications and product changes to relevant local and global stakeholders in a timely manner.
• Evaluate and update product labeling to ensure regulatory compliance while supporting commercial competitiveness and timely product launches.
• Maintain regulatory documentation records and databases including Regulatory Information Management Systems (RIMS) to ensure accuracy and compliance.
• Maintain required business licenses and import permits.
• Develop and implement local SOPs work instructions and processes to bridge gaps between global policies and local regulatory requirements.
• Ensure local implementation of global regulatory SOPs and mandatory training requirements.
• Monitor regulatory developments legislative changes industry trends and competitor activities and incorporate relevant insights into regulatory strategies.
• Support the introduction and launch of new products in collaboration with cross-functional teams.
• Build and maintain effective relationships with external stakeholders including the Ministry of Health Labour and Welfare (MHLW) Pharmaceuticals and Medical Devices Agency (PMDA) Tokyo Metropolitan Government (TMG) consultants and distributors.
• Support regulatory inspections audits and assessments by health authorities and certification bodies.
• Support post-market activities as needed.

Compliance:

• Lead the companys compliance program and promote adherence to global guidelines as well as local laws and regulations.
• Foster a culture of integrity ethics and compliance throughout the organization.
• Monitor compliance with internal standards and applicable regulations governing interactions with healthcare professionals (HCPs).

Vigilance Related Activities:

• Oversee the operation of the local vigilance system in compliance with global SOPs third-party agreements and local regulatory requirements.
• Review and approve local vigilance-related SOPs and supporting documentation.
• Act as Deputy Local Safety Officer and support the maintenance of a 24/7 vigilance coverage system.
• Ensure readiness for vigilance inspections and audits and support inspection activities as a key local contact.

Others:

• Lead coach develop and motivate Regulatory Affairs Quality and Vigilance team members.
• Foster strong and collaborative working relationships across functions.
• Represent the company in relevant industry associations working groups or professional committees when required.
• Partner with corporate functions on trademark management and trade compliance matters.
• Ensure compliance issues are appropriately investigated documented and addressed through effective Corrective and Preventive Action (CAPA) management.
• Comply with all applicable laws regulations the Galderma Code of Ethics company policies and SOPs.

• Bachelors degree or above in Pharmacy Life Sciences Engineering or a related discipline.
• A valid pharmacist license in Japan is preferred.

• Minimum 10 years of Regulatory Affairs experience within the medical device pharmaceutical industries.
• Experience developing regulatory strategies managing product registrations and supporting lifecycle management activities within the medical device sector.
• Experience working within a global or matrix organization.
• Strong knowledge of regulatory requirements and approval processes for medical devices pharmaceuticals in Japan.
• Experience leading or making significant contributions to product registrations from submission through approval.
• Experience interacting with regulatory authorities such as the Ministry of Health Labour and Welfare (MHLW) Pharmaceuticals and Medical Devices Agency (PMDA) and Tokyo Metropolitan Government (TMG).
• Working knowledge of Quality Management Systems (QMS) quality and safety-related requirements with experience partnering effectively across functions.
• Experience leading and developing small teams.

• Experience within cosmetics sectors.
• Experience within aesthetics dermatology or related healthcare sectors.

• Business-level proficiency in both English and Japanese written and spoken.

• A good understanding of the commercial drivers of the health care industry par-ticularly consumer health products and an associated ability to provide ad-vice/guidance that takes these into consideration
• Analytical skills and attention to detail with the capability to appropriately define issues questions and data and to propose solution to address the issues with appropriate level of sense of urgency
• Excellent communication skills: good positive and proactive communication and the ability to foster excellent working relations with both internal & external cus-tomers including the HA Industry Associations and internal stakeholders
• Skills such as project management problem solving ability to present infor-mation in easily understood format at internal and external meetings good time management negotiation and interpersonal skills
• Ability to work both independently hands-on - or as part of a team as required
• Be able to balance company commercial needs with compliance requirements
• Ability to think strategically and innovatively for resolution of regulatory issues envisioning the future and deciding on strategic priorities
• Commitment to continued improvement in function processes and performance
• Be a self-starter and proactively contributes to a positive team attitude and highly productive work environment
• Driving excellent execution and consequently delivering results
• High level of integrity and credibility
• Ability to combine strategic thinking with hands-on execution and lead by example.
• Ability to effectively communicate and promote understanding of QMS and regulatory requirements across the organization.
• Ability to build trust and collaborate effectively with diverse stakeholders.
• Open transparent and constructive communication style.
• Adaptability and resilience in a fast-paced and evolving business environment.