Description

　　Kenvue is currently recruiting for-

　　Senior Associate, Regulatory Affairs

　　This position will report into the Director, Regulatory Affairs based in Skillman, NJ or Fort Washington, PA.

　　Who we are

　　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 Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of 22,000 diverse and brilliant people, 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 the life of 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: Skillman, NJ or Fort Washington, PA.

　　Travel %: 15%

　　Pay: $84,000 to $135,700

　　What you will do

　　The Senior Associate, Regulatory Affairs is responsible for regulatory responsibility for products across needs-states, which may include Allergy, Upper Respiratory, and Pain and key brands such as TYLENOL Cold, SUDAFED, and ZYRTEC under a wide range of Regulatory classifications (NDA/ANDA, OTC Monograph Drug Products, and Cosmetics).

　　Responsibilities

　　Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classifications.

　　Labeling, digital, promotional review and approval, as well as other project execution and post-market related activities.

　　Support routine submissions to FDA, which may include preparing meeting requests and meeting background packages to FDA.

　　Assists in the development of best practices for Regulatory Affairs processes.

　　Ensures compliance within the department by ensuring global, regional, and local processes, policies, SOPs and working instructions are adhered to.

　　Use knowledge of regulatory landscape, competitive benchmarking, external factors to help shape and inform regulatory strategy.

　　Demonstrate successful collaboration and partnership across teams and functions within the organization.

　　Monitor competitive landscape and regulatory environment for new industry standards, FDA guidances, regulations, and draft legislation for impact to the business. May provide support to industry association(s) to provide comments to draft guidance and to help shape regulatory policy.

　　Kenvue operates in a highly regulated businesses environment. The Senior Associate, Regulatory Affairs will champion behaviors that embody Our Core Values.

　　Qualifications

　　What we are looking for

　　Required Qualifications

　　Bachelor's Degree in a science-related discipline is required.

　　4 years direct or indirect experience in Regulatory Affairs is required.

　　Working knowledge of regulatory requirements for various regulatory classifications (i.e., NDA/ANDA, OTC monograph drugs) is required.

　　Excellent communication, collaboration, and leadership skills are required.

　　Knowledgeable of the competitive landscape is required.

　　Technical/science-based background is required.

　　This position may require travel up to 15% to local sites in the area, as well as other locations based on business needs is required.

　　Desired Qualifications

　　An advanced degree (Masters, PhD, PharmD)

　　Knowledge of INDs, NDAs, ANDAs and OTC monograph products and a basic understanding of the Rx-to-OTC switch process are desirable.

　　Regulatory Affairs Certification (RAC) desirable.

　　What's in it for you

　　Annual base salary for new hires in this position ranges from $84,000 to $135,700. This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.

　　Competitive Total Rewards Package

　　Paid Company Holidays, Paid Vacation, Volunteer Time & More!

　　Learning & Development Opportunities

　　Employee Resource Groups

　　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 business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

　　#LI-LB2

　　Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity