Director of Regulatory Affairs
4 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. Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations
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. 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. 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.
Drive the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards.
Provide regulatory guidance and support to the New Product Development team to ensure compliance with EU regulations from the outset.
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.
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.
experience in the pharmaceutical industry minimum 8 years
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.
be flexible and strive for continuous improvement
We recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business.
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Regulatory Affairs Manager
5 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. 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...
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Regulatory Affairs Manager
4 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. 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
4 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. 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
4 weeks 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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