Regulatory Affairs Associate-2407017422WDescriptionKenvue is currently recruiting for: Regulatory Affairs AssociateThis position reports into the Senior Manager: Regulatory Affairs and is based in Cape Town, South Africa.Who We AreAt , 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®, BENYLIN®, 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 with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact 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, . What You Will DoThe Regulatory Affairs Associate oversees a range of regulatory activities for 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. Key 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 organizes 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. ·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 ·Assists in the maintenance of compliance for all products with local regulations and quality system requirements·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 othersQualificationsWhat We Are Looking ForRequired Qualifications ·Relevant bachelor's degree or higher·2+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 Core Competencies·Proficiency in English ·Excellent oral and written communicator·Able to work under pressure and to tight time deadlines·Able to work under own Initiative·Analytical thinker·Computer literate·Able to work effectively in a multi-cultural, highly matrixed organization What's In It For You·Competitive Benefit Package·Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & 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.Primary LocationEurope/Middle East/Africa-South Africa-Western Cape-Cape TownJob FunctionRegulatory AffairsOrganization:Johnson & Johnson (Proprietary) Limited
