Regulatory Affairs Manager
3 weeks ago
Ethypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Our commitment is to improve patients' lives and make a positive impact on society and the environment. Have you got what it takes to succeed The following information should be read carefully by all candidates. Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations Our six production sites located in France, the UK, Spain, and China have expertise in injectables and complex oral solid forms. With a global presence in 68 countries, the company markets its products directly in Europe and China, and has strategic partnerships in the EMEA, NA, LATAM and APAC markets. Ethypharm works closely with the authorities and healthcare professionals to ensure that its medicines are used appropriately and that patients have access to them. To find out more about Ethypharm, visit and follow us on LinkedIn. We are recruiting for a Regulatory Affairs Manager - EU. The role reports to Director of Regulatory Affairs and is based in our offices near High Wycombe managing a small team. This role is responsible for regulatory efforts for EU and UK products, particularly post-Brexit, where the Marketing Authorisation Holder (MAH) is Ethypharm SAS, France, while regulatory responsibilities remain under this role. The primary objective is to effectively fulfil MAH responsibilities for ESAS and other Ethypharm group entities concerning the UK portfolio. Key responsibilities Portfolio Management: Specialise in managing regulatory affairs for EU products within Ethypharm portfolio, ensuring adherence to relevant regulations and standards. Gap Analysis: Conduct thorough assessments of Marketing Authorisation (MA) versus manufacturing documents to identify and address any discrepancies. New MA Applications: Lead the preparation and submission of new Marketing Authorisation applications in the EU through various routes including National, Mutual Recognition, and Decentralised Procedures. Geographical Expansion: Drive the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards. RA Support for New Product Development: Provide regulatory guidance and support to the New Product Development team to ensure compliance with EU regulations from the outset. In-licensing Support: Offer regulatory support for in-licensing activities, ensuring smooth integration of acquired products into our portfolio. MA Compliance Maintenance: Ensure ongoing compliance and maintenance of Marketing Authorisations for the assigned portfolio of In-house manufacturing and Contract Manufacturing Organisations and oversee compliance for the team. Safety Variations: Ensure safety variations e.g. updating in line with reference products, PRAC recommendations, and Internal Safety updates for the assigned portfolio and oversee the Team submitting their assigned safety variations. Change Control Management: Manage regulatory change controls, Corrective and Preventive Actions (CAPAs), and deviations, with familiarity with the SAP system preferred. Implementation of Patient Information Leaflets (PILs) and Mock-ups: Oversee the comprehensive execution of PILs and mock-ups implementation, including finalising all procedural aspects, managing relevant national phases in each member state, collaborating with the artwork team and local affiliates/partners to create PIL mock-ups and artwork, and coordinating all necessary processes to ensure the timely implementation of new PIL mock-ups and artwork. About you Experience/Education
- experience in the pharmaceutical industry minimum 8 years
- science degree
- leadership and developing teams minimum 4 years.
- of working in a global matrix organisation and collaborating at all levels including external authorities and partners.
- Mutual Recognition and Decentralised Procedures.
- philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic “necessary” function.
- commercial sense, combined with an absolute commitment to high regulatory standards.
- planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation whilst maintaining attention to detail.
- effectively in both written and oral form
- be flexible and strive for continuous improvement
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Director of Regulatory Affairs
1 month ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations With a global...
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Director of Regulatory Affairs
1 month ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations With a global...
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Regulatory Affairs Manager
1 month ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Our commitment is to improve patients' lives and make a positive impact on society and the environment. Ethypharm has 1,700 employees...
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Regulatory Affairs Manager
1 month ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Our commitment is to improve patients' lives and make a positive impact on society and the environment. Ethypharm has 1,700 employees...
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Regulatory Affairs Manager
1 month ago
Wooburn Green, United Kingdom Ethypharm Full timeEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Our commitment is to improve patients' lives and make a positive impact on society and the environment. Ethypharm has 1,700 employees dedicated...
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Regulatory Affairs Manager
6 days ago
High Wycombe, Buckinghamshire, United Kingdom Trinityrec Full time2 days ago Be among the first 25 applicants Trinity Resource Solutions provided pay range This range is provided by Trinity Resource Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range Direct message the job poster from Trinity Resource Solutions Are you a Regulatory Affairs...
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Regulatory Affairs Manager
6 days ago
High Wycombe, Buckinghamshire, United Kingdom Trinityrec Full time2 days ago Be among the first 25 applicants Trinity Resource Solutions provided pay range This range is provided by Trinity Resource Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range Direct message the job poster from Trinity Resource Solutions Are you a Regulatory Affairs...
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Regulatory Affairs Scientific Leader
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Buckingham, Buckinghamshire, United Kingdom Harrison Scott Associates Full timeJob Title: Regional Regulatory Affairs Lead We are working with a group that owns a some of the most iconic sweet and savoury food brands. The objective of this role is to ensure the legal compliance of all products sold within UK&I market. The Regional Regulatory Affairs Lead will provide sound regulatory advice, support the launch & re-launch of products...
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Regulatory Affairs Scientific Leader
2 weeks ago
Buckingham, Buckinghamshire, United Kingdom Harrison Scott Associates Full timeJob Title: Regional Regulatory Affairs Lead We are working with a group that owns a some of the most iconic sweet and savoury food brands. The objective of this role is to ensure the legal compliance of all products sold within UK&I market. The Regional Regulatory Affairs Lead will provide sound regulatory advice, support the launch & re-launch of products...
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Regulatory Affairs Scientific Leader
2 days ago
Buckingham, Buckinghamshire, United Kingdom Harrison Scott Associates Full timeJob Title: Regional Regulatory Affairs Lead We are working with a group that owns a some of the most iconic sweet and savoury food brands. The objective of this role is to ensure the legal compliance of all products sold within UK&I market. The Regional Regulatory Affairs Lead will provide sound regulatory advice, support the launch & re-launch of products...
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Regulatory Affairs Scientific Leader
2 days ago
Buckingham, Buckinghamshire, United Kingdom Harrison Scott Associates Full timeJob Title: Regional Regulatory Affairs Lead We are working with a group that owns a some of the most iconic sweet and savoury food brands. The objective of this role is to ensure the legal compliance of all products sold within UK&I market. The Regional Regulatory Affairs Lead will provide sound regulatory advice, support the launch & re-launch of products...
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Buckinghamshire, United Kingdom TCS BIOSCIENCE Full timeInterested in joining our team at TCS Biosciences Ltd? We are looking for a Quality Assurance & Regulatory Affairs Assistant to join our team on a full time basis. Quality Assurance and Regulatory Affairs Assistant Full-time position, Monday to Friday, 37.5 hours per week Salary is negotiable depending on qualifications and experience Facility is situated...
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Aylesbury, Buckinghamshire, United Kingdom TCS BIOSCIENCE Full timeWe are looking for a Quality Assurance & Regulatory Affairs Assistant to join our team on a full time basis. Quality Assurance and Regulatory Affairs Assistant Full-time position, Monday to Friday, 37.Salary is negotiable depending on qualifications and experience Facility is situated in Botolph Claydon in the vicinity of Aylesbury, Buckingham and...
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Aylesbury, Buckinghamshire, United Kingdom TCS BIOSCIENCE Full timeWe are looking for a Quality Assurance & Regulatory Affairs Assistant to join our team on a full time basis. Quality Assurance and Regulatory Affairs Assistant Full-time position, Monday to Friday, 37.Salary is negotiable depending on qualifications and experience Facility is situated in Botolph Claydon in the vicinity of Aylesbury, Buckingham and...
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Senior Manager, Project Management
3 weeks ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. With a global...
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Senior Manager, Project Management
2 days ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. With a global...
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Senior Manager, Project Management
2 weeks ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. With a global...
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Aylesbury, Buckinghamshire, United Kingdom Aylesbury Full timeInterested in joining our team at TCS Biosciences Ltd? We are looking for a Quality Assurance & Regulatory Affairs Assistant to join our team on a full time basis. Quality Assurance and Regulatory Affairs Assistant Full-time position, Monday to Friday, 37.5 hours per week Salary is negotiable depending on qualifications and experience Facility is...
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Regional Regulatory Affairs Lead
1 week ago
Buckingham, Buckinghamshire, United Kingdom Harrison Scott Associates Full timeJob Title: Regional Regulatory Affairs Lead We are working with a group that owns a some of the most iconic sweet and savoury food brands. This is an unmissable opportunity to join a company that is not afraid to try new things, to experiment and strive for the impossible. Not only this, it a phenomenal place to work; everyone is a member of the global...
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Regional Regulatory Affairs Lead
2 weeks ago
Buckingham, Buckinghamshire, United Kingdom Harrison Scott Associates Full timeJob Title: Regional Regulatory Affairs Lead We are working with a group that owns a some of the most iconic sweet and savoury food brands. This is an unmissable opportunity to join a company that is not afraid to try new things, to experiment and strive for the impossible. Not only this, it a phenomenal place to work; everyone is a member of the global...
