Associate Director, Regulatory Affairs, CMC

Associate Director, Regulatory Affairs, CMC

O que fazemos

At Kenvue, percebemos o extraordinário poder do cuidado diário. Construída com base em mais de um século de herança e enraizada na ciência, somos a casa de marcas icônicas - incluindo NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® que você já conhece e ama. A ciência é a nossa paixão; O cuidado é o nosso talento.

Quem somos

Nossa equipe global é de ~ 22.000 pessoas brilhantes com uma cultura no local de trabalho onde cada voz é importante e cada contribuição é apreciada. Somos apaixonados por insights, inovação e comprometidos em entregar os melhores produtos aos nossos clientes. Com experiência e empatia, ser um Kenvuer significa ter o poder de impactar milhões de pessoas todos os dias. Colocamos as pessoas em primeiro lugar, nos importamos ferozmente, ganhamos confiança com a ciência e resolvemos com coragem - e temos oportunidades brilhantes esperando por você! Junte-se a nós para moldar nosso futuro - e o seu. Para obter mais informações, clique em aqui.

Role reporta para:

Vice President Regulatory Affairs NA

Location:

North America, United States, New Jersey, Summit

Local de trabalho:

Híbrido

O que você fará

The Associate Director, Regulatory Affairs CMC, is responsible for developing regulatory strategies and providing guidance to product development and commercial teams in support of Kenvue’s Skin Health and Beauty (SH&B) products Portfolio.

Key Responsibilities

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, annual reports, supplements and variations and responds to regulatory information.

• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.

• Ensure the timely submission of INDs, NDAs, amendments, and supplements for assigned  products/projects.

• Develops strategies for CMC agency meetings. Manages preparation for agency meetings, and content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.

• Manage products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.

• Represents CMC regulatory affairs on cross-functional teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.

• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization.

• Develops, implements, and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC.

• Serve as the Regulatory Affairs representative on project teams; manage the progress of projects by providing direction, solutions, and feedback to the teams.

• Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization, may include formal supervisory responsibilities

What we are looking for

Required Qualifications

• Minimum of 5 years of experience in Regulatory Affairs.

Desired Qualifications

• A minimum of a Bachelor’s degree is required, pharmacy, Chemistry, Biology or Pharmacology.

• Experience with INDs, NDAs, ANDA and leading health authority meetings.

• Experience working with industry counterparts and trade association committees and task groups is preferred.

• Experience working in a matrix environment. OTC industry experience preferred

• Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others

• Strong oral and written communication skills.

O que você ganha com isso

$166,600.00 - $235,200.00

Isso leva em consideração vários fatores, incluindo local de trabalho, habilidades do candidato, experiência, nível de educação e outros fatores relacionados ao trabalho.

A Kenvue tem orgulho de ser um empregador de oportunidades iguais. Todos os candidatos qualificados serão considerados para o emprego com base no mérito, independentemente de raça, cor, religião, sexo, orientação sexual, identidade de gênero, idade, nacionalidade ou status de veterano protegido e não serão discriminados com base na deficiência.