Regulatory Affairs Specialist
1 month ago
Job Title: Regulatory Affairs Specialist
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at eTeam Workforce Limited. As a key member of our Regulatory Affairs team, you will be responsible for managing post-approval activities for specified OTC products, supporting the EMEA Regulatory Affairs team, and developing regulatory strategies.
Key Responsibilities:
- Management of post-approval activities for specified OTC products.
- Support the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
- Development of regulatory strategies, preparation of regulatory applications, and support maintenance activities for MRP/DCP products.
- Support the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
- Support the team with regional regulatory strategies in line with business plan for post-approval activities.
- Complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
- Prepare and compile regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions, and other correspondence in accordance with EU regulations and guidelines.
- Ensure compliance within the department by ensuring EAME databases (RegPoint, HAQ) are fully maintained.
- Support the EMEA RA team with consolidated Calls for Information (CFI) and coordinate submission of PSUSA.
- Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the VP Regulatory Affairs in European Regulatory.
- Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
Requirements:
- Maintain awareness/knowledge of current regulatory legislation.
- Ensure regulatory best practice at all times.
- Monitor changes in the regulatory environment and highlight any potential impact on Kenvue's products.
Customer Service:
- Act as an ambassador for the Regulatory Affairs department to raise the profile of the team both internally and externally.
- Represent Regulatory Affairs on cross-functional product/project teams and provide regulatory advice (as appropriate).
- Interact with Regulatory Agency.
Education:
- Life sciences or chemistry graduate to honours level or equivalent.
Skills:
- Work with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
- Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial/strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations, etc.
-
Regulatory Affairs Specialist
1 day ago
High Wycombe, Buckinghamshire, United Kingdom ClinChoice Inc. Full timeJob Title: Regulatory Affairs SpecialistWe are seeking an experienced Regulatory Affairs Specialist to join our team at ClinChoice Inc. The ideal candidate will have a strong background in regulatory affairs, with a focus on over-the-counter (OTC) medicines.The salary for this role is estimated to be around $90,000 - $110,000 per annum, depending on...
-
Regulatory Affairs Specialist
1 month ago
High Wycombe, Buckinghamshire, United Kingdom newscientist - Jobboard Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ClinChoice. As a Regulatory Affairs Specialist, you will be responsible for supporting the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across the EEA and coordinating work-sharing procedures for CMC and...
-
Regulatory Affairs Specialist
1 month ago
High Wycombe, Buckinghamshire, United Kingdom newscientist - Jobboard Full timeRegulatory Affairs SpecialistClinChoice is seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of our Consumer Health department, you will be responsible for managing regulatory submissions and ensuring compliance with EU regulations and guidelines.Key Responsibilities:Develop and implement regulatory strategies for OTC...
-
Regulatory Affairs Specialist
1 month ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeRegulatory Affairs SpecialistKenvue is seeking a highly skilled 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.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with...
-
Regulatory Affairs Specialist
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom MSI Pharma Full timeJob Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our EMEA Regulatory Affairs team in the Cosmetics franchise. The successful candidate will develop regulatory strategies across the EMEA region, providing input and guidance to product development teams.Key Responsibilities:Collaborate...
-
Regulatory Affairs Specialist
1 month ago
High Wycombe, Buckinghamshire, United Kingdom Harrison Scott Associates Full timeJob Title: Regional Regulatory Affairs LeadWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Harrison Scott Associates. This is an exciting opportunity to work with a leading company in the food industry, driving business growth and ensuring regulatory compliance.The successful candidate will be responsible for ensuring the...
-
Regulatory Affairs Specialist
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom LanceSoft, Inc. Full timeJob DescriptionJob Title: Regulatory Affairs SpecialistLocation: Hybrid, with 1-2 days in the office per weekJob Type: Full-timeAbout LanceSoft, Inc.LanceSoft, Inc. is a leading company in the industry, and we are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Manage post-approval activities for specified OTC...
-
Regulatory Affairs Specialist
2 months ago
High Wycombe, Buckinghamshire, United Kingdom MSI Pharma Full timeJob Title: Senior Regulatory Affairs SpecialistLocation: Hybrid (South East England)Company: World-Leading Consumer Healthcare CompanyJob Purpose:As a Senior Regulatory Affairs Specialist, you will leverage your extensive knowledge of the regulatory landscape to ensure compliance and successful product registrations, including new drug applications,...
-
Regulatory Affairs Specialist
1 month ago
High Wycombe, Buckinghamshire, United Kingdom fish4.co - Jobboard Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at fish4.co - Jobboard. As a key member of our EMEA Regulatory Affairs team, you will be responsible for managing post-approval activities for specified OTC products, supporting the team with regulatory activities for European procedures, and ensuring compliance within...
-
Regulatory Affairs Senior Specialist
3 weeks ago
High Wycombe, Buckinghamshire, United Kingdom MSI Pharma Full timeSenior Regulatory Affairs Specialist (Cosmetics)Location: Hybrid - South East of EnglandMSI Pharma's Senior Regulatory Affairs Specialist will develop regulatory strategies across the EMEA region, providing input and guidance to product development teams within the Cosmetics franchise.Key Responsibilities:Collaborate with regulatory colleagues to create...
-
Regulatory Affairs Specialist
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom KENVUE Full timeJob SummaryKenvue is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing regulatory activities for a number of products within a therapy area for Cosmetics, OTC and/or Medical Devices in the UK, Ireland and Malta.Key ResponsibilitiesDevelop and...
-
Regulatory Affairs Specialist
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom KENVUE Full timeJob SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the success of our products by developing and implementing regulatory strategies, preparing regulatory applications, and maintaining compliance with local...
-
Regulatory Affairs Specialist
1 month ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeSenior Regulatory Affairs Specialist - Self CareKenvue is a leading global healthcare company that realizes the extraordinary power of everyday care. We are currently recruiting for a Senior Regulatory Affairs Specialist - Self Care to join our team.Key Responsibilities:Develop and implement global and regional regulatory strategies to support the Self Care...
-
Regulatory Affairs Specialist
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom eTeam Full timeJob DescriptionAs a Regulatory Affairs Specialist at eTeam, you will play a crucial role in managing post-approval activities for specified OTC products. Your responsibilities will include supporting the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products across the EEA and coordinating worksharing procedures for CMC and non-CMC...
-
Regulatory Affairs Specialist
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeRegulatory Affairs SpecialistThe Regulatory Affairs Specialist is accountable for all regulatory activities associated with their assigned medicines, medical devices, cosmetics, and/or food supplement consumer products within their geographical and/or brand area of responsibility.This role involves compilation and submission of applications (post-approval...
-
Regulatory Affairs Specialist
1 month ago
High Wycombe, Buckinghamshire, United Kingdom Hobson Prior Full timeHobson Prior is seeking a Senior Regulatory Specialist to develop strategies for regulatory affairs, prepare and submit regulatory submissions, and maintain awareness of current regulations.Key Responsibilities:Collaborate with local and regional colleagues to create global and/or regional regulatory strategies.Prepare and submit regulatory submissions in...
-
Regulatory Affairs Specialist Self Care
3 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeThe Regulatory Affairs Specialist is accountable for all regulatory activities associated with their assigned medicines, medical devices, cosmetics, and/or food supplement consumer products within their geographical and/or brand area of responsibility. This includes compilation and submission of applications, resolution of Health Authority questions, and...
-
Regulatory Affairs Specialist
3 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeRole SummaryThe Senior Regulatory Affairs Specialist Self Care will be responsible for developing global and regional regulatory strategies, coordinating regulatory actions, and developing global/regional dossiers to support local review processes.Key ResponsibilitiesWork with local and regional regulatory colleagues to develop global and/or regional...
-
Regulatory Affairs Specialist
3 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Kenvue Full timeThe Regulatory Affairs Associate plays a key role in ensuring the compliance of Kenvue products with local regulations and quality system requirements. This position oversees a range of regulatory activities for assigned medicines, medical devices, cosmetics, and/or food supplements within the UK, Ireland, and Malta.The successful candidate will assist in...
-
Regulatory Affairs Specialist
2 weeks ago
High Wycombe, Buckinghamshire, United Kingdom CK Group Full timeJob Title: Regulatory Affairs ManagerCK Group is seeking a highly skilled Regulatory Affairs Manager to join their team. This is a contract role based in High Wycombe, requiring a strong understanding of post-approval activities for OTC products.Key Responsibilities:Support the EMEA Regulatory Affairs team with post-approval activities for MRP/DCP products...