Business Services & Consulting • Charvil, England, United Kingdom
Kenvue is currently recruiting for a:
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 - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.
Who We Are
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 .
Role reports to:
Associate Director, Regulatory AffairsLocation:
Europe/Middle East/Africa, United Kingdom, Reading, BerkshireWork Location:
HybridWhat 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.
---
**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.
Kenvue is currently recruiting for a:
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 - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.
Who We Are
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 .
Role reports to:
Associate Director, Regulatory AffairsLocation:
Europe/Middle East/Africa, United Kingdom, Reading, BerkshireWork Location:
HybridWhat 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.
---
**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.
