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：

Senior CMC Manager

位置：

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

工作地点：

混合

你会做什么

The Regulatory Affairs Specialist is accountable for all regulatory activities associated with EMEA medicinal products. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested. This position reports into the Associate Director Regulatory Affairs and is based at Reading (hybrid).

What You Will Do 

·         Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations.

·         Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.

·         Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.

·         Prioritizes, plans and monitors allocated projects against defined timelines

·         Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements

·         Ensures that all assigned products comply with local regulatory and quality system requirements.

·         Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained

·         Identifies & initiates local process improvement opportunities and manage changes as required

·         Assists in the preparation for internal and external audits and inspections in collaboration with others

·         Partner with other critical functions to execute plans to address crises and other sensitive issues

 

 

Qualifications : 

 

Required Qualifications

·         Relevant Bachelor's Degree or higher 

·         4+yrs related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).

·         Good attention to details.

·         Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.

·         Good interpersonal skills; able to build effective personal networks internally and externally.

·         Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.

·         Strong organizational and time management skills with an ability to work under pressure.

·         Able to work effectively in a multi-cultural, highly matrixed organization

·         Proficiency in English

 

Desired Qualifications

·         Knowledge of consumer healthcare environment and product development

·         Understanding of processes and departments within a healthcare company

·         Effective time and organisation management

 

What’s In It For You

·         Competitive Benefit Package

·         Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

·         Learning & Development Opportunities

·         Employee Resource Groups 

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