Senior Associate Regulatory Affairs at Kenvue Brands LLC in Summit, New Jersey

Job Description:

Description

Upcoming Senior Associate Regulatory Affairs (Essential Health) opportunities here at Kenvue

Location: Summit, New Jersey, US

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® 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 lives of millions of people every day. We put people first, care fiercely, earn trust with science, and solve with courage - and we have brilliant opportunities waiting for you! Join us in shaping our future-and yours.

What will you do

We're launching an exciting (job title/function) opportunity soon and would love to connect if you're interested in learning more. We look forward to reviewing your application should you apply.

The Senior Associate of Regulatory Affairs leads the regulatory affairs deliverables for the Essential Health franchise ensuring the success of new product registrations, line extensions and new claims in alignment with the business plan, while overseeing compliance for all products with relevant regulations and quality system requirements.

Key Responsibilities

• Responsible for end-to-end regulatory activities for assigned oral care, wound care, and cosmetic brands.
• Executes well-constructed and considered regulatory strategies that keep pace with the dynamic Essential Health environment.
• Builds strong relationships with all stakeholders, internal and external.
• Represent regulatory affairs on assigned projects, providing guidance and executing regulatory strategies. Includes review of formulas for global and local acceptability and claims development. Requires some OTC Drug and medical device products in portfolio.
• Collaborate with Global and US stakeholders (commercial, Global Regulatory, R&D etc.) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and success
• Provide regulatory support to ex-US markets for brands where US is the Lead Market (as defined through SRA). Support end-to-end regulatory compliance of products in remit.
• Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
• Proactively identify potential regulatory risks and recommend solutions within defined scope of responsibility on the business.
• Review labeling and formulations for acceptability.

Major Duties & Responsibilities

The Roles & Responsibilities include:

Regulatory Strategy

• Provides strategic input and technical guidance on global/regional regulatory requirements to product development teams.
• Evaluates risks of product and recommends regulatory solutions.
• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified
• Provides regulatory guidance on strategy for proposed product claims/labeling to ensure compliance with the local regulatory requirements to optimize the proposed product positioning.
• Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process

Regulatory Compliance

• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products
• Ensure that all applicable Processes, SOPs and working instructions are adhered to.
• Support internal and external audits and inspections in collaboration with quality function
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).
• Identify local process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives

Regulatory Advocacy

• Remains up-to-date on scientific and clinical advances that impact healthcare product development and assesses the relationship to regulation and regulatory issues.
• Drive new approaches to improve the development, review and oversight of regulatory frameworks for healthcare products.
• Engages with stakeholder groups to help shape science based regulatory decision making as required

What we are looking for

Qualifications

• Relevant Bachelor's Degree or higher
• 3 yrs related regulatory experience
• Expertise across a broad spectrum of Regulatory classifications including, Cosmetics, drug Products and/or Medical Devices
• Ability to work in a highly matrixed environment

What's In It for You

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment 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.

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