Reading, England, United Kingdom · Hybrid
Kenvue is currently recruiting for a: Regulatory Affairs Specialist What we do 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…
Skills: Regulatory Strategy, Drug Application Submission, MRP, DCP, Workshare
Summit, New Jersey, United States · Hybrid
$124k–$175k/yr
Kenvue is currently recruiting for a: Regional Supplier Lifecycle Manager What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the ho…
Skills: Supplier Lifecycle Management, Packaging Component Expertise, Supplier Quality, Risk Management, GMP Compliance
Bangkok, Thailand · On-site
Kenvue is currently recruiting for a: Line Support Engineer What we do 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 …
Skills: Mechanical Troubleshooting, Electrical Troubleshooting, PLC, Pneumatics, Preventive Maintenance
Sydney, New South Wales, Australia · Hybrid
Kenvue is currently recruiting for a: Logistics Specialist What we do 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 b…
Skills: Trade Compliance, Customs Regulations, HS Code Classification, Supplier Relationship Management, Data Analysis
Summit, New Jersey, United States · Hybrid
$111k–$156k/yr
Kenvue is currently recruiting for a: Assoc. Mgr Category Insights to Action What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the…
Skills: Category Management, Data Analysis, Shopper Insights, Strategic Planning, Syndicated Data Analysis
Mumbai, Maharashtra, India · Hybrid
Kenvue is currently recruiting for a: Head ERLR India What we do 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…
Skills: Employee Relations, Labor Relations, Collective Bargaining, Contract Interpretation, Performance Management
Bangalore, Karnataka, India · Hybrid
Kenvue is currently recruiting for a: EMEA Data Product Owner - Commercial Data Products What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in scienc…
Skills: Product Management, Data Product Roadmap, Stakeholder Engagement, Requirements Gathering, Retail Execution
Petaling Jaya, Selangor, Malaysia · On-site
Kenvue is currently recruiting for a: Warehousing and Transportation Operations Manager - MYSG What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in …
Skills: Warehousing Management, Logistics Management, Customer Service Management, Order To Cash Process, ERP Systems
Shanghai, Shanghai, China · On-site
Kenvue is currently recruiting for a: Summer Intern, R&D What we do 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 bra…
Skills: R&D Support, Technical Analysis, Regulatory Compliance, Medical Science Support, Market Analysis
São José dos Campos, São Paulo, Brazil · On-site
Kenvue is currently recruiting for a: Movimentador Logístico - Vaga para Pessoa com Deficiência. What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted i…
Skills: Warehouse Operations, Inventory Counting, Loading and Unloading, Pallet Jack Operation, ERP Systems
Markham, Ontario, Canada · Hybrid
$93k–$143k/yr
Kenvue is currently recruiting for a: Professional Marketing Manager, Pain and Oral Care What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in scienc…
Skills: Healthcare Marketing, Strategic Business Planning, Omni-channel Marketing, Market Insights, Budget Management
Summit, New Jersey, United States · Hybrid
$170k–$176k/yr
Employer: Kenvue Brands LLC Job Title: IT Lead DataOps Data Engineer Job Code: B378.101 Job Location: Summit, NJ Job Type: Full-Time Rate of Pay: $169,541 - $176,322 Job Duties: Lead the development and implementation of…
Skills: Data Warehousing, Data Integration, Data Analytics, Data Visualization, Data Governance
Guelph, Ontario, Canada · Hybrid
$72k–$116k/yr
Kenvue is currently recruiting for a: Senior Packaging Development Specialist What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re th…
Skills: Packaging Design, Technical Writing, Project Management, Change Management, Validation Protocols
Summit, New Jersey, United States · Hybrid
$124k–$175k/yr
Kenvue is currently recruiting for a: Manager, Shopper Insights What we do 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 ico…
Skills: Shopper Insights, Category Management, Market Research, Omnichannel Strategy, Data Analytics
Summit, New Jersey, United States · On-site
$154k–$217k/yr
Kenvue is currently recruiting for a: Sr Supply Planning Manager - Skin Health What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re t…
Skills: Supply Planning, Inventory Management, People Leadership, S&OP Process, MRP
Bangalore, Karnataka, India · Hybrid
Kenvue is currently recruiting for a: Lead Analyst Retail Analytics - CBI RGM What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re th…
Skills: Revenue Growth Management, Data Analytics, SQL, Python, R
Seoul, South Korea · Hybrid
Kenvue is currently recruiting for a: Head of Regulatory Affairs, Korea What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the hous…
Skills: Regulatory Affairs Management, Strategic Planning, People Leadership, Compliance, Policy Shaping
Seoul, South Korea · Hybrid
Kenvue is currently recruiting for a: Site Delivery Lead (Fixed-Term, 1 Year) What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re th…
Skills: IT Infrastructure Management, End-User Services, Vendor Management, ITIL Framework, Stakeholder Management
Cheongju-si, Chungcheongbuk-Do, South Korea · On-site
Kenvue is currently recruiting for a: Filling Operator What we do 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 brand…
Skills: Production Equipment Operation, Quality Control Inspection, Equipment Maintenance, Troubleshooting, Documentation
Dubai, Dubai, United Arab Emirates · On-site
Kenvue is currently recruiting for a: eContent & Design Lead What we do 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…
Skills: Content Strategy, Content Creation, Design Management, Leadership, Digital Marketing
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Responsible for regulatory activities for assigned medicines, including the compilation and submission of applications and resolution of Health Authority questions. The role involves managing post-approval commitments, variations, and ensuring compliance with local regulatory and quality system requirements.
Requires a Bachelor's degree or higher and at least 4 years of related regulatory experience. Candidates must have hands-on experience with EU/EMEA registration activities for medicines and strong communication skills.
Kenvue is currently recruiting for a:
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 ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are 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 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
Regulatory Affairs Specialist
The Regulatory Affairs Specialist is responsible for all regulatory activities associated with assigned medicines within their geographical and/or brand area of responsibility. This role involves the compilation and submission of applications (new submissions and post-approval), resolution of Health Authority questions in cooperation with other functions, and the management of post-approval commitments and variations/renewal applications as needed.
What you will do
- Assist in the development of regulatory strategies across the EMEA region, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
- Coordinate, compile, and submit new drug applications to regulatory agencies within their geographical and/or brand area of responsibility.
- Manage MRP, DCP, and Workshare submission activities for medicines.
- Develop effective partnerships with R&D, Franchise (Marketing), and local regulatory colleagues.
- Collect and evaluate information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Prepare and submit regulatory submissions for the registration and maintenance of products throughout their lifecycle, according to applicable regulatory requirements and guidelines.
- Monitor the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
- Prioritize, plan, and monitor allocated projects against defined timelines.
- Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
Regulatory Compliance
- Ensure that all assigned products comply with local regulatory and quality system requirements.
- Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
- Stay aware of current regulations and anticipate implications and opportunities arising from changes in the regulatory environment.
- Participate in the development and implementation of applicable processes, SOPs, and working instructions.
- Ensure that enterprise regulatory systems are accurate and fully maintained.
- Review and escalate compliance issues, implementing relevant corrective/preventative actions locally.
- Identify and implement regional process improvement opportunities and ensure the implementation of relevant global or regional regulatory initiatives.
- Assist in the preparation for internal and external audits and inspections in collaboration with others.
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Specific Requirements
- Relevant Bachelor's Degree or higher.
- 4+ years of related regulatory experience.
- Represent Regulatory Affairs on cross-functional product/project teams and provide regulatory advice.
- Apply organizational understanding and awareness in decision-making.
- Utilize effective communication and influencing skills to develop key relationships with internal/external contacts.
*Essential Knowledge
- Knowledge of the consumer healthcare environment and product development.
- Hands-on experience with regulatory requirements and registration activities for medicines in the EU/EMEA.
- Understanding of regulatory frameworks and external environments, with the ability to apply these to regulatory solutions throughout the product lifecycle.
- Solid understanding of regulatory, medical, safety, and quality requirements in relevant markets.
- Familiarity with processes and departments within a healthcare company.
Core Competencies:
- Excellent communication skills, capable of articulating concepts clearly both verbally and in writing, especially when simplifying complex regulatory or technical issues.
- Strong interpersonal skills; able to build effective personal networks internally and externally.
- Collaborative with a strong sense of ownership, accountability, and recognition for delivering results.
- Strong organizational and time management skills, with the ability to work under pressure.
- Ability to work effectively in a multi-cultural, highly matrixed organization.
- Proficiency in English.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
A new view of care 🤍
Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage and propelled forward by science, our iconic brands — including Aveeno®, BAND-AID® Brand Adhesive Bandages, Johnson’s®, Listerine®, Neutrogena®, Tylenol® and Zyrtec® — are recommended by health care professionals and can be trusted by consumers who use our products to improve their daily lives. Our team members share a digital-first mindset, with an approach to innovation grounded in deep human insights and work every day to earn a place for our products in consumers’ hearts and homes. At Kenvue, we believe everyday care can not only make people well; it can make them whole. Beware of recruitment scams: https://www.kenvue.com/media/recruitment-scams-alert
Offices: Summit, New Jersey 07901, US
A new view of care 🤍
Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage and propelled forward by science, our iconic brands — including Aveeno®, BAND-AID® Brand Adhesive Bandages, Johnson’s®, Listerine®, Neutrogena®, Tylenol® and Zyrtec® — are recommended by health care professionals and can be trusted by consumers who use our products to improve their daily lives. Our team members share a digital-first mindset, with an approach to innovation grounded in deep human insights and work every day to earn a place for our products in consumers’ hearts and homes. At Kenvue, we believe everyday care can not only make people well; it can make them whole. Beware of recruitment scams: https://www.kenvue.com/media/recruitment-scams-alert
Offices: Summit, New Jersey 07901, US
