Regulatory Affairs Specialist

Regulatory Affairs Specialist

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

Associate Director, Regulatory Affairs

位置：

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

工作地点：

混合

你会做什么

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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