Senior Associate - Regulatory Affairs

Senior Associate - Regulatory Affairs

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.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Director Regulatory Affairs

Location:

North America, United States, New Jersey, Summit

Work Location:

Hybrid

What you will do

The Senior Associate of Regulatory affairs is responsible for ensuring compliance with regulatory agency regulations, preparing responses to regulatory agencies' questions, and gathering necessary information for submissions:

Key Responsibilities

• Lead the development and implementation of regulatory strategies for new product submissions
• Provide regulatory guidance and support to cross-functional teams
• Prepare and submit regulatory filings to health authorities
• Stay current on regulatory requirements and communicate changes to internal stakeholders
• Conduct regulatory intelligence activities to assess impact on product development
• Lead and manage regulatory activities for a diverse portfolio of products
• Collaborate with regulatory agency personnel to expedite approval of applications and resolve complex regulatory issues
• Develop and implement regulatory strategies to achieve department and company objectives
• Ensure strict compliance with global, regional, and local regulations, policies, and procedures
• Prepare and submit high-quality regulatory submissions and responses to agencies in a timely manner
• Create and monitor detailed timelines for regulatory submissions
• Communicate effectively with key stakeholders on project/product updates
• Contribute to the development of best practices for Regulatory Affairs processes
• Maintain accurate and organized regulatory documentation
• Coordinate and manage reporting schedules efficiently
• Assist in the preparation of comprehensive regulatory reports and presentations
• Ensure adherence to quality and compliance standards in all regulatory activities

What we are looking for

Required Qualifications

• University/Bachelors Degree in a related field
• 4-6 years of experience in regulatory affairs
• Strong knowledge of global regulatory requirements
• Ability to work effectively in a fast-paced environment and manage multiple projects simultaneously
• 4-6 years of experience in handling regulatory data for regulated products such as OTC Drugs, Cosmetics, and Medical Devices
• Proficiency in Word, Excel, PowerPoint, Email, and Internet applications
• Familiarity with Regulatory processes including Drug Listing, IDMP, and Periodic Safety Reporting

Desired Qualifications

• Excellent communication and interpersonal skills
• Strong attention to detail with exceptional documentation skills and problem-solving abilities
• Excellent interpersonal skills with a collaborative and solution-oriented approach
• Ability to multitask and deliver high-quality work under pressure
• Effective communication and stakeholder management skills

What’s in it for you

$100,300.00 - $141,600.00

This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

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.