Regulatory Affairs Specialist

Regulatory Affairs Specialist

Lo que hacemos

En Kenvue, nos damos cuenta del extraordinario poder del cuidado diario. Sobre la base de más de un siglo de herencia y arraigados en la ciencia, somos el hogar de marcas icónicas, incluidas NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® y BAND-AID® que ya conoces y amas. La ciencia es nuestra pasión; El cuidado es nuestro talento.

Quiénes somos

Nuestro equipo global está formado por ~ 22.000 personas brillantes con una cultura laboral en la que cada voz importa y cada contribución es apreciada. Nos apasionan las ideas, innovación y comprometidos con la entrega de los mejores productos a nuestros clientes. Con experiencia y empatía, ser un Kenvuer significa tener el poder de impactar a millones de personas todos los días. Ponemos a las personas en primer lugar, nos preocupamos ferozmente, nos ganamos la confianza de la ciencia y resolvemos con coraje, ¡y tenemos oportunidades brillantes esperándote! Únase a nosotros para dar forma a nuestro futuro y al suyo. Para obtener más información, haga clic en aquí.

Role reports to:

Senior CMC Manager

Ubicación:

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

Lugar de trabajo:

Híbrido

What will you

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 

Si usted es una persona con una discapacidad, consulte nuestra página de Disability Assistance para obtener información sobre cómo solicitar una adaptación.