Kenvueは現在、以下求人を募集しております。
Regulatory Affairs Specialist私たちがしていること
私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。
Who We Are
私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。
Role reports to:
Associate Director, Regulatory Affairs場所:
Europe/Middle East/Africa, United Kingdom, Reading, Berkshire勤務地:
ハイブリッドあなたがすること
Regulatory Affairs Specialist
The Regulatory Affairs Specialist is responsible for all regulatory activities associated with assigned medicines within their geographical and/or brand area of responsibility. This role involves the compilation and submission of applications (new submissions and post-approval), resolution of Health Authority questions in cooperation with other functions, and the management of post-approval commitments and variations/renewal applications as needed.
What you will do
- Assist in the development of regulatory strategies across the EMEA region, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
- Coordinate, compile, and submit new drug applications to regulatory agencies within their geographical and/or brand area of responsibility.
- Manage MRP, DCP, and Workshare submission activities for medicines.
- Develop effective partnerships with R&D, Franchise (Marketing), and local regulatory colleagues.
- Collect and evaluate information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Prepare and submit regulatory submissions for the registration and maintenance of products throughout their lifecycle, according to applicable regulatory requirements and guidelines.
- Monitor the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
- Prioritize, plan, and monitor allocated projects against defined timelines.
- Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
**Regulatory Compliance**
- Ensure that all assigned products comply with local regulatory and quality system requirements.
- Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
- Stay aware of current regulations and anticipate implications and opportunities arising from changes in the regulatory environment.
- Participate in the development and implementation of applicable processes, SOPs, and working instructions.
- Ensure that enterprise regulatory systems are accurate and fully maintained.
- Review and escalate compliance issues, implementing relevant corrective/preventative actions locally.
- Identify and implement regional process improvement opportunities and ensure the implementation of relevant global or regional regulatory initiatives.
- Assist in the preparation for internal and external audits and inspections in collaboration with others.
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**Specific Requirements**
- Relevant Bachelor's Degree or higher.
- 4+ years of related regulatory experience.
- Represent Regulatory Affairs on cross-functional product/project teams and provide regulatory advice.
- Apply organizational understanding and awareness in decision-making.
- Utilize effective communication and influencing skills to develop key relationships with internal/external contacts.
*Essential Knowledge
- Knowledge of the consumer healthcare environment and product development.
- Hands-on experience with regulatory requirements and registration activities for medicines in the EU/EMEA.
- Understanding of regulatory frameworks and external environments, with the ability to apply these to regulatory solutions throughout the product lifecycle.
- Solid understanding of regulatory, medical, safety, and quality requirements in relevant markets.
- Familiarity with processes and departments within a healthcare company.
**Core Competencies:**
- Excellent communication skills, capable of articulating concepts clearly both verbally and in writing, especially when simplifying complex regulatory or technical issues.
- Strong interpersonal skills; able to build effective personal networks internally and externally.
- Collaborative with a strong sense of ownership, accountability, and recognition for delivering results.
- Strong organizational and time management skills, with the ability to work under pressure.
- Ability to work effectively in a multi-cultural, highly matrixed organization.
- Proficiency in English.
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