Regulatory Affairs Manager
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Posted:
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Job Summary
Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.
We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.
At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.
学歴資格
- 薬学製薬科学化学生物学またはその他のライフサイエンス関連分野の学士号を有すること
- 修士号保有者は尚可
職務経験
- 日本における化粧品およびまたは医薬部外品領域で薬事業務に関する実務経験を8年以上有すること
- 製品の承認届出申請から上市後のライフサイクルマネジメントまで一貫して担当した経験
- グローバル企業などのマトリックス組織での業務経験
- 日本の化粧品医薬部外品規制に関する深い知識を有すること
- 製品届出
- 各種ライセンス要件
- 表示広告および効能表現のコンプライアンス
- 原料規制
- 市販後対応
- 化粧品医薬部外品に関する規制評価申請承認取得および上市後維持管理を主体的にリードした経験
- 化粧品医薬部外品に関する規制対応について行政当局や業界団体との折衝経験
語学
- 日本語ネイティブレベルまたは流暢
- 英語ビジネスレベル
- 化粧品医薬部外品業界の事業特性を理解しコンプライアンスを維持しながら事業目標達成に貢献できる実践的な薬事アドバイスを提供できること
- 複雑な規制課題を分析しリスクや機会を見極めたうえで適切な解決策を導き出せる高い分析力論理的思考力
- 規制当局業界団体本社グローバル部門および社内関係部署との良好な関係構築ができる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力
- 専門知識の有無に関わらず相手に応じて規制関連事項を分かりやすく説明できる能力
- 複数案件を同時に管理し期限内に成果を出すためのプロジェクトマネジメント能力計画力交渉力および対人スキル
- マトリックス組織の中で自律的かつ協調的に業務を推進し関係者を巻き込みながら目標達成へ導けること
- 規制動向の変化を先読みし事業への影響を評価しながら製品開発承認取得市場導入ライフサイクルマネジメントに対して戦略的な提言ができること
- 業務プロセスやシステムの継続的改善に取り組み効率性コンプライアンス組織能力の向上に貢献できること
- 高い主体性と実行力を持ち施策を最後までやり遂げられること
- 高い倫理観信頼性コンプライアンス意識を有すること
- Bachelors degree in Pharmacy Pharmaceutical Sciences Chemistry Biology or other relevant Life Sciences discipline.
- Minimum 8 years of progressive Regulatory Affairs experience in the cosmetics and/or quasi-drugs industry including direct responsibility for product registrations and lifecycle management in Japan.
- Experience working in an international matrix organisation.
- Strong knowledge of Japanese regulations and registration requirements governing cosmetics and quasi-drugs including product notifications licensing requirements labeling advertising and claims compliance ingredient regulations and post-market obligations.
- Demonstrated experience leading end-to-end regulatory assessments submissions registrations approvals and lifecycle maintenance activities for cosmetics and quasi-drug products in Japan.
- Experience interacting with Japanese regulatory authorities and industry associations regarding cosmetics and quasi-drug regulatory matters.
- Fluent Japanese communication skills.
- Business-level English communication skills.
- Strong understanding of the commercial dynamics of the cosmetics and quasi-drugs industry with the ability to provide pragmatic regulatory guidance that supports business objectives while ensuring compliance.
- Strong analytical and critical thinking skills.
- Excellent communication stakeholder management and influencing skills.
- Strong project management planning negotiation and interpersonal skills.
- Ability to work independently and collaboratively in a matrix environment.
- Strategic mindset with the ability to anticipate regulatory developments and provide actionable regulatory guidance.
- Commitment to continuous improvement of regulatory processes systems and ways of working.
- Self-motivated proactive and results-oriented approach.
- High level of integrity professional credibility and commitment to ethical conduct and compliance.
- Masters degree.
Required Experience:
Manager
