Kenvue · 1 month ago
Associate Director, Regulatory Affairs, CMC
Summit, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
$167K/yr - $235K/yr
5+ years expKenvue is a company dedicated to everyday care and is known for its iconic brands. The Associate Director, Regulatory Affairs CMC, will develop regulatory strategies and guide product development for Kenvue’s Skin Health and Beauty products, ensuring compliance with regulatory submissions and agency meetings.
LifestylePersonal HealthWellness
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
Qualification
Required
Minimum of 5 years of experience in Regulatory Affairs
Preferred
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
Benefits
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Kenvuer Impact Networks
Company
Kenvue
Kenvue is a consumer health company that delivers personal health solutions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$3.65BKey Investors
Third PointStarboard Value
2025-11-03Acquired
2025-04-25Post Ipo Equity
2024-10-21Post Ipo Equity
Leadership Team
Kirk Perry
Chief Executive Officer and Director at Kenvue
Andrew Stanleick
President, Skin Health & Beauty, North America and EMEA at Kenvue
Recent News
Hindu Business Line
2026-01-22
Benzinga.com
2026-01-20
Company data provided by crunchbase