Associate Director, Regulatory Affairs, CMC

Associate Director, Regulatory Affairs, CMC

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

Vice President Regulatory Affairs NA

位置：

North America, United States, New Jersey, Summit

工作地点：

混合

你会做什么

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.

对您有什么好处

$166,600.00 - $235,200.00

这考虑了许多因素，包括工作地点、候选人的技能、经验、教育水平和其他与工作相关的因素

Kenvue 很自豪能成为一个机会均等的雇主。所有合格的申请人都将根据业绩获得就业考虑，不分种族、肤色、宗教、性别、性取向、性别认同、年龄、国籍或受保护的退伍军人身份，并且不会因残疾而受到歧视。