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Senior Associate, Regulatory Affairs
4 months ago
Description
Kenvue, is currently recruiting for:
Senior Associate, Regulatory Affairs
This position reports into Associate Director, Regulatory Affairs and is based Skillman , NJ, USA.
Who we are
At Kenvue , we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands-including NEUTROGENA , AVEENO , TYLENOL , LISTERINE , JOHNSON'S and BAND-AID -are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers' hearts and homes. Join us in shaping our future-and yours. Watch us here .
Role reports to: Associate Director, Regulatory Affairs
Location: Skillman, NJ Kenvue's corporate headquarters is currently located in Skillman NJ , but is scheduled to move to Summit, NJ in or around early 2025.
Travel %: 10%
Pay Range: $100K - $120K
What will you do
This position resides in Regulatory Affairs within the R&D organization. The Senior Associate, Regulatory Affairs, will have regulatory responsibility for Digestive Health products, which include key brands such as IMODIUM, PEPCID and LACTAID under a wide range of Regulatory classifications (NDA/ANDA, OTC Monograph Drug Products, and Dietary Supplements).
Key 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.
What we are looking for
Required Qualifications
A minimum of a Bachelor's Degree in a science-related discipline is required.
A minimum of 4 years direct or indirect experience in Regulatory Affairs or an advanced degree (Masters, PhD, PharmD, etc.) is required.
Knowledge of INDs, NDAs, ANDAs and OTC monograph products and a basic understanding of the Rx-to-OTC switch process a are desirable.
Regulatory Affairs Certification (RAC) desirable.
Working knowledge of regulatory requirements for various regulatory classifications (i.e., NDA/ANDA, OTC monograph drugs)
Excellent communication, collaboration, and leadership skills are required.
Knowledgeable of the competitive landscape
Technical/science-based background
*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.
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
