Senior Director, Regulatory Affairs

Senior Director, 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:

Vice President Regulatory Affairs NA

Location:

North America, United States, New Jersey, Summit

Lugar de trabajo:

Híbrido

What will you

The Senior Director, Regulatory Affairs, is a seasoned regulatory professional with in-depth knowledge of FDA regulatory requirements and guidelines. Responsible for developing and executing regulatory strategies and providing guidance to product development and commercial teams in support of Kenvue’s Self-care product Portfolio. The ideal individual must have proven ability to thrive in a collaborative cross-functional environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, negotiation and strong communication skills.  and adaptability is required for this position

What you will do 

Key Responsibilities

• Provide strategic guidance to the organization in support of creative regulatory strategies for the US and Global Allergy portfolio.
• Liase with the FDA and serve as RA lead for Health Authority meetings for innovation products and marketed products.
• In-dept knowledge and experience with RX-to-OTC Switch
• The ability to influence effectively in a matrixed environment
• Proactively scan and engage in the external environment and provide regulatory intelligence and insights to internal teams to anticipate and prepare for changing regulatory requirements.
• Leverage your knowledge of the consumer healthcare products industry to shape internal product development, claims, and labeling processes such that they are efficient, compliant and fit-for-purpose.
• Interface with senior leaders in business to develop, implement, and maintain policies and standards
• Oversee and provide guidance to the regulatory team approving budgets, strategies, product claims in accordance with internal procedures and external guidelines
• Oversee the technical team responsible for creation and maintenance of Self-care product innovation labeling.
• Develop and maintain procedures for key regulatory processes.
• Set objectives for RA SC team members in alignment with organizational goals and objectives.
• Perform other duties as assigned

What we are looking for

Required Qualifications

• Minimum of 10 years of experience in Regulatory Affairs.

Desired Qualifications

• A minimum of a Bachelor’s degree is required, preferably in a science-related or legal field. Advance degree preferred but not required.
• Experience with INDs, NDAs, ANDA, RX-to OTC Switch and leading health authority meetings.
• Experience working with industry counterparts and trade association committees and task groups is preferred.
• A proactive, big picture strategic thinker who can distill complex scenarios into simplified guidance for internal teams.

What's in it for you

$242,250.00 - $342,000.00

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.