AD, Regulatory Affairs CMC
Kenvue, Summit, NJ, United States
What We Do
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.
Position Associate Director, Regulatory Affairs CMC
Role Reports To VP Regulatory Affairs NA
Location North America, United States, New Jersey, Summit
Work Location Hybrid
What You Will Do The Associate Director, Regulatory Affairs CMC, is responsible for developing regulatory strategies and providing guidance to product development and commercial teams.
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.
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.
What’s In It For You Annual base salary for new hires in this position ranges: $166,600.00 - $235,200.00.
Competitive Benefit Package*
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Kenvuer Impact Networks
This list could vary based on location/region
Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
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Position Associate Director, Regulatory Affairs CMC
Role Reports To VP Regulatory Affairs NA
Location North America, United States, New Jersey, Summit
Work Location Hybrid
What You Will Do The Associate Director, Regulatory Affairs CMC, is responsible for developing regulatory strategies and providing guidance to product development and commercial teams.
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.
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.
What’s In It For You Annual base salary for new hires in this position ranges: $166,600.00 - $235,200.00.
Competitive Benefit Package*
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Kenvuer Impact Networks
This list could vary based on location/region
Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
#J-18808-Ljbffr