Regulatory Affairs Specialist
3 days ago
Senior Regulatory Affairs Specialist
Kenvue Inc is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing regulatory strategies across the EMEA region and globally.
Key Responsibilities:
- Develop Global and Regional Regulatory Strategies: Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results and develops global/regional dossiers to support local review processes.
- Prepare and Submit Regulatory Submissions: Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
- Track Regulatory Status: Track the status of applications under regulatory review and provides updates to the regulatory team.
- Stay Up-to-Date with Regulatory Legislation: Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level.
- Monitor Regulatory Environment: Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
- Compliance and Audits: 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. 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 quality function.
- Regulatory Partnerships: Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.). Supports in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).
- Business Partnerships: Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
- Leadership and Coaching: Works with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit.
Requirements:
- Relevant Degree: Relevant Bachelor's Degree or higher.
- Experience: At least 5 years of relevant working experience.
- Regulatory Expertise: Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices.
- Regulatory Knowledge: Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
- Leadership Skills: Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance. Leadership and coaching skills with experience of people development.
- Language Skills: Proficiency in English.
-
Regulatory Affairs Specialist
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom CK Group- Science, Clinical and Technical Full time £64CK Group is seeking a Regulatory Affairs Specialist to join a prominent organization in the Pharmaceutical sector on a contractual basis. Compensation: £18 per hour PAYE or £86.00 per hour via umbrella. Key Responsibilities: Assist the EMEA Regulatory Affairs team with post-approval processes for MRP/DCP products across the EEA. Contribute to the...
-
Regulatory Affairs Specialist
2 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Pharmiweb Full timePharmiweb Seeks Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmiweb. This is a full-time hybrid role that offers a dynamic work environment and the chance to make a significant impact in Class I, II, and III medical devices.Key Responsibilities:Develop and implement regulatory strategies...
-
Regulatory Affairs Specialist
5 days ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeJob Summary**Senior Regulatory Affairs Specialist – Self Care**We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our consumer products in the UK, Ireland, and...
-
Regulatory Affairs Specialist
7 days ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeJob Summary**Senior Regulatory Affairs Specialist – Self Care**We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our consumer products in the UK, Ireland, and...
-
Regulatory Affairs Specialist
3 days ago
High Wycombe, Buckinghamshire, United Kingdom MSI Pharma Full timeExciting Opportunity for a Regulatory Affairs Specialist at MSI PharmaWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at MSI Pharma. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies for EMEA and global markets.Key Responsibilities:Develop and implement...
-
Regulatory Affairs Specialist
3 days ago
High Wycombe, Buckinghamshire, United Kingdom MSI Pharma Full timeExciting Opportunity for a Regulatory Affairs Specialist at MSI PharmaWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at MSI Pharma. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies for EMEA and global markets.Key Responsibilities:Develop and implement...
-
Regulatory Affairs Specialist
4 days ago
High Wycombe, Buckinghamshire, United Kingdom MSI Group Limited Full timeJob Title: Senior Regulatory AffairsMSI Group Limited is seeking a highly skilled Regulatory Affairs Specialist to join our team in a full-time hybrid role. This position offers a dynamic work environment and the chance to make a significant impact in Class I, II, and III medical devices.Key Responsibilities:Develop and implement regulatory strategies for...
-
Regulatory Affairs Specialist
4 days ago
High Wycombe, Buckinghamshire, United Kingdom MSI Group Limited Full timeJob Title: Senior Regulatory AffairsMSI Group Limited is seeking a highly skilled Regulatory Affairs Specialist to join our team in a full-time hybrid role. This position offers a dynamic work environment and the chance to make a significant impact in Class I, II, and III medical devices.Key Responsibilities:Develop and implement regulatory strategies for...
-
Regulatory Affairs Specialist
2 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeRegulatory Affairs SpecialistKenvue is seeking a highly skilled Regulatory Affairs Specialist to join our team and drive regulatory excellence in the consumer products industry. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Regulatory Compliance: Assist...
-
Regulatory Affairs Specialist
2 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for our consumer products in the UK, Ireland, and Malta.Key ResponsibilitiesCoordinate and submit regulatory applications to...
-
Regulatory Affairs Specialist
5 days ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for our consumer products in the UK, Ireland, and Malta.Key ResponsibilitiesCoordinate and submit regulatory applications to...
-
Regional Regulatory Affairs Specialist
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeRegulatory Affairs SpecialistManages regulatory functions for designated products across the UK, Ireland, and MaltaPrepares and submits regulatory applications, addressing inquiries from Health AuthoritiesReports to the Associate Director of Regulatory AffairsPosition available in a hybrid work modelAbout KenvueAt Kenvue, we are committed to enhancing...
-
Regional Regulatory Affairs Specialist
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeRegulatory Affairs SpecialistManages regulatory functions for designated products across the UK, Ireland, and MaltaPrepares and submits regulatory applications, addressing inquiries from Health AuthoritiesReports to the Associate Director of Regulatory AffairsOperates in a hybrid work environmentAbout UsAt Kenvue, we are committed to enhancing everyday...
-
Regulatory Affairs Specialist
7 days ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies across the EMEA region and globally.Key ResponsibilitiesDevelop global and/or regional regulatory strategies, coordinating regulatory actions...
-
Regulatory Affairs Specialist
5 days ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our consumer products in the UK, Ireland, and Malta.Key ResponsibilitiesCoordinate and submit regulatory applications to relevant...
-
Regulatory Affairs Specialist
2 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our consumer products in the UK, Ireland, and Malta.Key ResponsibilitiesCoordinate and submit regulatory applications to relevant...
-
Regulatory Affairs Director
7 days ago
High Wycombe, Buckinghamshire, United Kingdom Tarsh & Partners Marketing Recruitment Full timeJob Summary:We are seeking an experienced Senior Manager Regulatory Affairs Specialist to join our team at Tarsh & Partners Marketing Recruitment. As a key member of our client's consumer healthcare team, you will be responsible for managing and supporting a portfolio of consumer healthcare brands.Key Responsibilities:Regulatory Strategy Development: Develop...
-
Senior Manager Regulatory Affairs Specialist
7 days ago
High Wycombe, Buckinghamshire, United Kingdom Tarsh & Partners Marketing Recruitment Full timeJob Summary:We are seeking an experienced Senior Manager Regulatory Affairs Specialist to join our team at Tarsh & Partners Marketing Recruitment. As a key member of our consumer healthcare team, you will be responsible for managing and supporting a portfolio of consumer healthcare brands.Key Responsibilities:Regulatory Strategy Development: Develop and...
-
Regulatory Affairs Director
1 week ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeRegulatory Affairs Leadership OpportunityAbout KenvueKenvue is a global leader in delivering quality products to customers. Our team of talented individuals focuses on innovation and customer satisfaction.Job SummaryWe are seeking a highly skilled Senior Manager, Regulatory Affairs, CMC to lead our Regulatory Affairs team. The successful candidate will be...
-
Senior Regulatory Affairs SME
2 months ago
High Wycombe, Buckinghamshire, United Kingdom MSI Pharma Full timeAre you an expert in Regulatory strategies with a passion for medical devices? We are seeking a Senior Regulatory Affairs Specialist to lead and develop regulatory strategies across the EMEA region and globally. The role is Hybrid and will working in the Berkshire / Bucks area. Key Responsibilities:Coordinate Regulatory Deliverables: Manage regulatory...