Regulatory Affairs Director

... tracking, v-TMF build & upload). Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions. Creation/distribution of regulatory binders & the wet-ink signed documents binder. Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions. Assist in providing internal ...

... you'll need to be a Registered Nurse (RGN) with a current NMC registration and a mentoring or supervision qualification. Experience of producing care plans and detailed risk assessments is important, as is an up-to-date knowledge on the most recent clinical practices. We'll also look for an understanding of regulatory frameworks, including DoLs/MCA and Royal Pharmaceutical guidelines. You'll be a natural leader and problem solver who has worked with older people and acted as a clinical mentor, including supporting newly qualified nurses through their preceptorship. Dedicated, ambitious and resilient, you'll have a strong ...

... and respected for what you do. ABOUT YOU You'll need to have current NMC registration and a good knowledge of the most up-to-date clinical practices to join us as a Registered Nurse (RGN). Experience of producing well-developed care plans and detailed risk assessments is important too, as is an understanding of regulatory frameworks, including DoLs/MCA and Royal Pharmaceutical guidelines. Dedicated and compassionate, you'll pride yourself on your person-centred, thoughtful approach to nursing. REWARDS PACKAGE As well as a competitive salary, Barchester offers one of the best rewards packages in the care sector. Your generous benefits ...

... worldwide. Our Policy & Government Affairs team collaborate with government entities and policy organizations at local and national levels. We address legislative and regulatory issues that promote the discovery and ... animal health products while improving and protecting patient access to care. Our team, within the External Affairs Department provides strategic and tactical communications and policy leadership and support to our UK ... with approval from the External Affairs Director. Duties These are just some examples of activities or initiatives you could get involved with during your time with our External Affairs team: Strategic ...

... for a Regulatory Affairs Manager to join ... queries regarding regulatory issues concerning ... with significant regulatory experience in the ... Affairs Manager to lead a Regulatory ... the provision of regulatory support to ... services. The Regulatory Affairs Manager will ... related to regulatory issues in the ... associations and Regulatory Authorities, ... latest relevant regulatory information in ... the Regional Regulatory Director. Key ... Affairs team to ensure effective provision of ... queries related to regulatory issues concerning ... associations and Regulatory Authorities as ... with the latest regulatory information in ... Director. Ensure compliance with ... teams to integrate regulatory considerations ... and guidance on regulatory matters to ... in quality, regulatory, or manufacturing. ... a regulatory role Familiarity with regulatory ...

... in the UK. Based with the operational office in Edinburgh, Scotland, you will be a member of the Executive Management Team and will be supported by the Asset Director and Head of Finance. Your role as Executive General Manager will be responsible for and ensuring that all aspects of running the project as a business are ... including managing the PPA. * Contract Management. * Governance & Management of Stakeholders shareholders, government authorities, local communities. * Regulatory Affairs: ensure compliance with permits and consents of the company, influence policy developments (with support of contractors). The Executive General Manager will ...

Director of Quality Assurance (Hybrid role) About the Company: ... a dynamic and experienced Director of Quality Assurance to ... team in Oxfordshire. Director of Quality Assurance - ... software solutions. The Director of Quality Assurance will ... of quality assurance and regulatory compliance to ensure that ... standards and regulatory requirements. Director of Quality ... Quality Management: The Director of Quality Assurance will ... Staying up-to-date with regulatory changes, guiding the ... audits and regulatory inspections, the Director will ensure ... and records to support regulatory submissions and audits. ... assurance and regulatory affairs in the medical device ... quality assurance and regulatory compliance efforts. ...

... If you are interested, we recommend submitting your application now to avoid missing out. For further information, please do not hesitate to call Andrew Welsh, Director of Medical Devices Recruitment and Scientific Recruitment Specialist at Newton Colmore, on (phone number removed), or submit an application, and a member of our Newton Colmore team will contact you. Newton Colmore Consulting is a specialist recruitment company within the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance, and Field Service Engineering sectors

... looking for a Regulatory Affairs Manager for a ... within their Regulatory Affairs team on an ... Trial Application regulatory strategies and ... overarching global regulatory strategy and any ... to the Global Regulatory Project Team and ... with global regulatory strategies and ... and maintain regulatory databases, data ... and tracking of regulatory submissions. ... Represent regulatory perspective in ... overarching global regulatory strategy ... Represent area regulatory in clinical trial ... Associate Director, provide regulatory ... with Global Regulatory Leads and subject ... Director with planning and tracking of ... experience in Regulatory Affairs including ... and evolving regulatory environment, Good ...

... Engagement team, reporting to the Customer Engagement Director. The Executive Case Manager will form part of the ... additional intervention from our legal or public affairs teams. Key Responsibilities: * Be a main representative ... policy, procedures & regulatory standards. * Work in conjunction with our Director of Communications and Legal ... managing and working with the Customer Engagement Director to ensure the relevant action is taken when a case is ... the wider team to gain a greater understanding of regulatory requirements to support the Divisional Customer ...

... Career Pathways SUMMARY: The Associate Director, Quality Assuranceis responsible for ... experience in Quality Assurance, Regulatory Affairs, Laboratory Operations or a related ... * Experience managing quality/regulatory department of regional responsibility * ... Medicines & Healthcare products Regulatory Agency (MHRA), Food & Drug ... vendor audits, client audits and regulatory inspections, to ensure compliance. ... working knowledge of industry and regulatory standards and requirements. Provide ... MHRA, FDA, data privacy and other regulatory standards as needed or directed. Serve ... Laboratories at client meetings, regulatory audits, and more. Additional Job ...

... lot of interest. So, if you are interested, I suggest making an application now or risk missing out. For more information, please feel free to call Andrew Welsh, Director of Medical Devices recruitment and Scientific recruitment specialists at Newton Colmore, on (phone number removed), or make an application, and one of our team at ... contact you. Newton Colmore Consulting is a specialist recruitment company within the Medical Devices, Scientific Engineering, Data Science, Machine Learning, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance, and Field Service Engineering sectors

... and managing income, debt and deferred payments in line with regulatory and policy requirements. Deliver innovative approaches that ... closely with the Strategic Director of Transformation, Integration & Assurance, the Assistant Director for Transformation, as well ... Assessments and Income Collection team and the Client Financial Affairs team (approximately 90 FTE). Financial Assessments and Income ... Care debt collection and deferred payments. Client Financial Affairs Team who are responsible for circa £15m of funds in managing the ... deferred payments are made in line with all statutory and regulatory requirements. 3. Lead the design, delivery and embedding of ...

... income, debt and deferred payments in line with regulatory and policy requirements. Deliver innovative approaches ... with the Strategic Director of Transformation, Integration & Assurance, the Assistant Director for Transformation, ... and Income Collection team and the Client Financial Affairs team (approximately 90 FTE). Financial Assessments and ... collection and deferred payments. Client Financial Affairs Team who are responsible for circa £15m of funds in ... payments are made in line with all statutory and regulatory requirements. 3. Lead the design, delivery and embedding ...

... Regulatory Affairs Manager Role: As Regulatory Affairs ... reporting into the Director or Regulatory Affairs with the ... you will provide global regulatory support to sales and ... and information. Regulatory Affairs Manager Responsibilities: ... standards in line with regulatory requirements To work with ... out to support global regulatory requirements Take a central ... regular communication with regulatory requirements Assist with the ... documents from the regulatory perspective Clear operation ... departments to resolve regulatory related issues in ... members of staff Regulatory Affairs Manager skills: Degree ... experience in a regulatory role within the medical ...

... to: Sr. Director, Regulatory Science CMC ... CMC contact to internal parties and ... of CMC regulatory strategy, notably ... to be submitted to regulatory authorities ... products. Lead regulatory CMC activities for ... high quality regulatory submissions while ... provide relevant regulatory guidance and ... for meeting regulatory requirements are ... date knowledge of regulatory CMC requirements ... changes in regulatory information to ... transparency of regulatory CMC information to ... functions and Regulatory CMC colleagues. ... to ensure that regulatory documents are ... compliance with regulatory requirements ... information from regulatory authorities ... intelligence on regulatory CMC matters that ... personnel Collaborate with global Regulatory CMC ... Extensive regulatory affairs industry ... Significant regulatory CMC experience ... that comply with regulatory requirements is a ... regulatory authorities Regulatory Affairs ...

... and Data Protection Administrator accordingly Carrying out other reasonable duties as directed by the Director of Operations or Chief Executive Person Specification We are looking for someone with a strong intellect, ... and to advise and brief accordingly. Essential requirements Some understanding of the political and current affairs environment. Administrative experience of office record-keeping and/or case management systems. Intellectual ... of the Liberal Democrats. Law Degree or CILEx level 3, plus at least 2 years experience in a claims or regulatory environment Desirable skills & experience Some knowledge of working organisational constitutions, or ...

... looking for a Regulatory Affairs Manager for a ... within their Regulatory Affairs team on an ... Role: Deliver CTA regulatory strategies and ... overarching global regulatory strategy and any ... to the Global Regulatory Project Team and ... with global regulatory strategies and ... and maintain regulatory databases, data ... and tracking of regulatory submissions. ... Represent regulatory perspective in ... overarching global regulatory strategy ... Represent area regulatory in clinical trial ... Associate Director, provide regulatory ... with Global Regulatory Leads and subject ... Director with planning and tracking of ... experience in Regulatory Affairs including ... and evolving regulatory environment, Good ...