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Regulatory Associate Regional SH
Location:
High Wycombe, Bucks
Description:
Description Kenvue is currently recruiting for: Regulatory Affairs Associate The Regulatory Affairs Associate oversees a range of regulatory activities for their assigned medicines, medical devices, cosmetics and/or food supplement consumer products within UK, Ireland and Malta. 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. This position reports into the Associate Director Regulatory Affairs and is based at High Wycombe (hybrid). 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 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, click here . What You Will Do • Assists in the coordination, compilation & submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within UK, Ireland and Malta for their 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. • 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 (if relevant). • Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator. • Monitors progress of applications against set timelines, acting where necessary to minimize delays and anticipate difficulties. • Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained. • Tracks the status of applications under regulatory review and provides updates to the wider Kenvue teams. • Assists in the identification & initiation of local process improvement opportunities and manages changes as required. • Assists in the preparation for internal and external audits and inspections in collaboration with others. • Assists and ensures compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally. • Assists in trade association, working groups, developing impact assessments influencing regulatory strategies, and leading solutions at a local level (if relevant). • Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility. • Participates in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions. Required Qualifications • Relevant Bachelor's Degree or higher • 2 yrs related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP). • Good attention to details. • 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 Desired Qualifications • Knowledge of consumer healthcare environment and product development • Knowledge of regulatory frameworks and external environments, and the ability (under supervision) to apply these to regulatory solutions throughout the product lifecycle • Understanding of processes and departments within a healthcare company • Effective time and organisation management 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.
Company:
Johnson & Johnson
Posted:
June 21 on Equest
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More About this Listing: Regulatory Associate Regional SH
Regulatory Associate Regional SH is a Jobs Regulatory Associate Regional Job at Johnson & Johnson located in High Wycombe BKM. Find other listings like Regulatory Associate Regional SH by searching Oodle for Jobs Regulatory Associate Regional Jobs.
Regulatory Associate Regional SH is a Jobs Regulatory Associate Regional Job at Johnson & Johnson located in High Wycombe BKM. Find other listings like Regulatory Associate Regional SH by searching Oodle for Jobs Regulatory Associate Regional Jobs.