Senior Regulatory Affairs Associate

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どんな仕事かAIによる生成

規制当局への申請管理と、適用される法律・ガイドラインへの準拠を担当します。部門横断チームと協力し、製品承認を支援して規制関連文書を維持します。規制戦略の策定、規制情報レポートの作成、社内研修の実施、デジタルツールやAI分析の活用にも取り組みます。

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Bachelor's degree in a relevant scientific or regulatory field
Minimum of 3 years experience in regulatory affairs or related domain
Strong understanding of regulatory guidelines and compliance requirements
Experience in regulatory affairs for OTC pharmaceutical products
Proven ability to interpret and synthesize scientific data
Effective communication skills for preparing regulatory documentation
Work experience using English in Multinational company or domestic company (TOEIC 700 or more)

Pharmacist or master degrees in a relevant science
Work experience in Consumer industry (OTC drugs, Quasi-drugs, Cosmetics, Medical devices for consumer use, food, etc)
Expertise in navigating complex regulatory landscapes with innovative problem-solving
Experience in crafting persuasive regulatory narratives and stakeholder presentations
Proficiency in leveraging technology and data analytics for regulatory process improvement
Strategic foresight in regulatory affairs and compliance monitoring

Proactive approach with a commitment to continuous learning and pioneering novel regulatory methods

The Senior Regulatory Affairs Associate is responsible for managing regulatory submissions and ensuring compliance with applicable laws and guidelines. You will collaborate with cross-functional teams to support product approvals and maintain regulatory documentation:

Pioneer the development and implementation of cutting-edge regulatory strategies that streamline product approvals while ensuring full compliance with global standards.
Collaborate cross-functionally with R&D and marketing teams to translate complex regulatory requirements into innovative product labeling and communication strategies.
Lead the creation of dynamic regulatory intelligence reports that anticipate industry shifts and proactively adapt company policies.
Design and execute interactive training modules to elevate regulatory awareness and agility across the organization.
Champion the integration of emerging digital tools and AI-driven analytics to enhance regulatory submission accuracy and efficiency.

この求人は、JNTLコンシューマーヘルス株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト

応募はJNTLコンシューマーヘルス株式会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。