Regulatory Affairs Specialist

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

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Was Sie tun werden

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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