Description 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 . Job Purpose The Regulatory Affairs Specialist is accountable for all regulatory activities associated with their assigned medicines, medical devices, cosmetics and/or food supplement consumer products within their geographical and/or brand area of responsibility.
Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested. Essential duties and responsibilities Regulatory Strategy * Assists in the coordination, compilation & submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility. * Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations. * Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines. * Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible. * Prioritizes, plans and monitors allocated projects against defined timelines * Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements Regulatory Compliance * Ensures that all assigned products comply with local regulatory and quality system requirements. * Reviews and approves promotional materials for assigned local Kenvue products. * Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator. * Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained. * Identifies & initiates local process improvement opportunities and manage changes as required * Assists in the preparation for internal and external audits and inspections in collaboration with others. Job Requirements * Relevant Bachelor's Degree or higher * 4 yrs related regulatory experience * Knowledge of consumer healthcare environment and product development * Understanding of processes and departments within a healthcare company * Effective time and organisation management * Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues. * Good interpersonal skills; able to build effective personal networks internally and externally. * Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results. * Strong organizational and time management skills with an ability to work under pressure. * Able to work effectively in a multi-cultural, highly matrixed organization * Proficiency in English