Senior Associate - Regulatory Affairs

Senior Associate - Regulatory Affairs

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:

Director Regulatory Affairs

Location:

North America, United States, New Jersey, Summit

Lugar de trabajo:

Híbrido

What will you

The Senior Associate of Regulatory affairs is responsible for ensuring compliance with regulatory agency regulations, preparing responses to regulatory agencies' questions, and gathering necessary information for submissions:

Key Responsibilities

• Lead the development and implementation of regulatory strategies for new product submissions
• Provide regulatory guidance and support to cross-functional teams
• Prepare and submit regulatory filings to health authorities
• Stay current on regulatory requirements and communicate changes to internal stakeholders
• Conduct regulatory intelligence activities to assess impact on product development
• Lead and manage regulatory activities for a diverse portfolio of products
• Collaborate with regulatory agency personnel to expedite approval of applications and resolve complex regulatory issues
• Develop and implement regulatory strategies to achieve department and company objectives
• Ensure strict compliance with global, regional, and local regulations, policies, and procedures
• Prepare and submit high-quality regulatory submissions and responses to agencies in a timely manner
• Create and monitor detailed timelines for regulatory submissions
• Communicate effectively with key stakeholders on project/product updates
• Contribute to the development of best practices for Regulatory Affairs processes
• Maintain accurate and organized regulatory documentation
• Coordinate and manage reporting schedules efficiently
• Assist in the preparation of comprehensive regulatory reports and presentations
• Ensure adherence to quality and compliance standards in all regulatory activities

What we are looking for

Required Qualifications

• University/Bachelors Degree in a related field
• 4-6 years of experience in regulatory affairs
• Strong knowledge of global regulatory requirements
• Ability to work effectively in a fast-paced environment and manage multiple projects simultaneously
• 4-6 years of experience in handling regulatory data for regulated products such as OTC Drugs, Cosmetics, and Medical Devices
• Proficiency in Word, Excel, PowerPoint, Email, and Internet applications
• Familiarity with Regulatory processes including Drug Listing, IDMP, and Periodic Safety Reporting

Desired Qualifications

• Excellent communication and interpersonal skills
• Strong attention to detail with exceptional documentation skills and problem-solving abilities
• Excellent interpersonal skills with a collaborative and solution-oriented approach
• Ability to multitask and deliver high-quality work under pressure
• Effective communication and stakeholder management skills

What's in it for you

$100,300.00 - $141,600.00

Esto tiene en cuenta una serie de factores que incluyen la ubicación del trabajo, las habilidades del candidato, la experiencia, el nivel de educación y otros factores relacionados con el trabajo.

Kenvue se enorgullece de ser un empleador que ofrece igualdad de oportunidades. Todos los solicitantes calificados recibirán consideración para el empleo basada en el mérito sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, edad, origen nacional o estado de veterano protegido y no serán discriminados por motivos de discapacidad.