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Sr Reg Affairs Specialist Self Care, High Wycombe
Client:
Kenvue Location:
High Wycombe, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
032db4010ec9 Job Views:
81 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
Senior Regulatory Affairs Specialist – Self Care The Senior Regulatory Affairs Specialist is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise. This position reports into the Associate Director Regulatory Affairs and is based at High Wycombe (hybrid). Who We Are
Kenvue realizes 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 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 to have the power to impact the lives 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. What You Will Do
Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results, and developing global/regional dossiers to support local review processes. Organize materials from preclinical and clinical studies for review and assist in the review process. Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines. Assist in scheduling meetings with internal stakeholders and regulators and develop and organize materials for these meetings. Track the status of applications under regulatory review and provide updates to the regulatory team. Familiarize and understand current regulatory legislation to keep legislative knowledge up to date at the regional level. Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders. Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments. Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs, and working instructions. Ensure that the enterprise Regulatory systems are accurate and fully maintained. Review and escalate any compliance issues and implement relevant corrective/preventative actions locally. Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives. Support internal and external audits and inspections in collaboration with the quality function. Monitor the regulatory environment (specific regulations, guidance, and other relevant information by product types, geography, etc.) and maintain information resources. Support in trade associations, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local levels (if relevant). Provide technical and leadership development as appropriate. Monitor the progress of applications of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties. Partner with the business to deliver regulatory outcomes to enable committed business plans within the area of responsibility. Work with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit. Qualifications
Primary Location:
Europe/Middle East/Africa-United Kingdom-England-High Wycombe Job Function:
Regulatory Affairs
#J-18808-Ljbffr
Client:
Kenvue Location:
High Wycombe, United Kingdom Job Category:
Other EU work permit required:
Yes Job Reference:
032db4010ec9 Job Views:
81 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
Senior Regulatory Affairs Specialist – Self Care The Senior Regulatory Affairs Specialist is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise. This position reports into the Associate Director Regulatory Affairs and is based at High Wycombe (hybrid). Who We Are
Kenvue realizes 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 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 to have the power to impact the lives 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. What You Will Do
Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results, and developing global/regional dossiers to support local review processes. Organize materials from preclinical and clinical studies for review and assist in the review process. Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines. Assist in scheduling meetings with internal stakeholders and regulators and develop and organize materials for these meetings. Track the status of applications under regulatory review and provide updates to the regulatory team. Familiarize and understand current regulatory legislation to keep legislative knowledge up to date at the regional level. Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders. Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments. Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs, and working instructions. Ensure that the enterprise Regulatory systems are accurate and fully maintained. Review and escalate any compliance issues and implement relevant corrective/preventative actions locally. Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives. Support internal and external audits and inspections in collaboration with the quality function. Monitor the regulatory environment (specific regulations, guidance, and other relevant information by product types, geography, etc.) and maintain information resources. Support in trade associations, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local levels (if relevant). Provide technical and leadership development as appropriate. Monitor the progress of applications of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties. Partner with the business to deliver regulatory outcomes to enable committed business plans within the area of responsibility. Work with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit. Qualifications
Primary Location:
Europe/Middle East/Africa-United Kingdom-England-High Wycombe Job Function:
Regulatory Affairs
#J-18808-Ljbffr
