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Position: Quality Specialist Location: Slough, UK Client: Biotechnology Type: Contract - full-time Main Responsibilities • Support the implementation and ongoing maintenance of the company’s Quality Management System (QMS), ensuring accurate and timely handling of records such as deviations, change controls, and complaints., • Identify compliance gaps and recommend appropriate corrective and preventive actions (CAPAs)., • Ensure CAPAs are properly documented, monitored, and completed within agreed timelines., • Monitor, analyse, and report on quality metrics and key performance indicators., • Review and approve batch documentation to enable timely release of products to the market., • Prepare Annual Product Quality Reviews in line with internal procedures and schedules., • Coordinate stability programs for locally managed products., • Assist with internal self-inspection activities and audits., • Contribute to management reviews of quality systems and processes. Main Requirements • Bachelor’s degree in a Life Sciences field (such as Biology, Chemistry, or Pharmacy)., • Ideally 1–2 years of experience in a pharmaceutical quality-related role., • Strong organisational skills with the ability to manage tasks through to completion., • Excellent written and verbal communication skills., • High level of accuracy and attention to detail., • Proficiency in Microsoft Office applications (e.g. Excel, Word, Outlook). ABOUT PLANET PHARMA Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

Senior Regulatory Affairs Manager – Europe A European‑focused regulatory role supporting the development, registration, and lifecycle management of speciality, orphan, paediatric, and generic medicines. Key Responsibilities • Develop and execute EU regulatory strategies for innovative, speciality, and complex products., • Review non‑clinical and clinical data packages and identify gaps for regulatory submissions., • Lead/assist with MAAs, variations, line extensions, renewals, and post‑approval commitments., • Support regulatory interactions, including scientific advice and dossier due diligence (Modules 1–5)., • Coordinate registrations across centralised, DCP, MRP, and national procedures., • Provide input across cross‑functional development teams and oversee documentation systems., • Support EU launch requirements and guide junior team members where needed. Required Experience • Experience with ophthalmology products (eye drops, ophthalmic solutions)., • Experience leading Health authority interactions and scientific advice meetings, • Knowledge of medical devices/combination products, ideally ophthalmic., • Proven background in injectable/sterile products and related regulatory submissions., • Strong EU regulatory experience including MAAs, DCP/MRP, lifecycle management, and scientific advice., • Understanding of requirements for placing medicines on the EU market., • Hands on, proactive regulatory with authoring and submission experience Skills & Qualifications • Degree in Pharmacy, Life Sciences, or similar., • Proficient with regulatory tools (eCTD publishing, CESP, MHRA Portal, etc.)., • Strong analytical, communication, and project‑management capabilities., • Must be a proven regulatory SME in speciality pharma Due to the nature of this roles hands-on, fast pace work, this role is not suitable for Regulatory Project Manager or those who have not directly authored dossier and lead review of both clinical and non clinical data package. All applicants must have clearly demonstrated experience with health authority interaction as an active/ leading member of meetings. Hybrid based from Slough SL1.

LEAPING FORWARD TO MAKE PEOPLE SMILE At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life‑changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work. Overview Senior Medical Director, Haem-Oncology at Kyowa Kirin International plc Marlow, UK (hybrid) WE PUSH THE BOUNDARIES OF MEDICINE. At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life‑changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work. Job Purpose You will be the primary lead for Acute Myeloid Leukaemia (AML) and will provide strategic medical leadership and expertise for AML programmes across the KKI region working closely with global colleagues. The role will play a key part in driving the company’s AML programme through medical affairs leadership, cross‑functional collaboration, and active support for clinical trial delivery in partnership with Clinical Development. Key Responsibilities Provide medical and scientific leadership for medical affairs AML programmes across the EMEA region Development and implementation of the regional pre‑launch medical strategy in line with the global strategy for the company’s AML medicine Serve as a subject matter expert in AML, offering consultation and guidance to internal teams and external partners Act as the primary point of contact to address scientific enquiries and deliver presentations on disease state Collaborate closely with global functions such as Medical, HEOR, Clinical Development and Clinical Operations Develop and lead the execution medical education programs related to AML for internal staff (Clinical staff project teams), and external stakeholders (Investigators, KEE’s, external CROs) Regional lead for all external regional company activities at all relevant haematology‑oncology related events (congresses, conferences, etc.) Represent the Medical Affairs function in all relevant cross‑functional project teams, business development activities and external engagements Sit on KKI Medical Affairs Leadership Team Position Requirements Qualified Physician (MD) required; with specialisation in Haematology and/or Oncology preferred Significant experience in haematology or oncology, preferably with AML expertise, in clinical development, medical affairs, or related pharmaceutical industry roles within the EMEA region, with a strong preference for an established network of key external experts in the EMEA region in AML Demonstrated expertise in the design, execution, and oversight of haematology or oncology clinical trials, including experience with regulatory requirements and safety monitoring Proven ability to work effectively in cross‑functional, matrixed teams Strong leadership, communication, and presentation skills, with fluency in English (additional EMEA languages an advantage) Ability to work independently in a remote environment and travel as required (average ~35%, with potential for periods up to 50%) Kyowa Kirin International is an equal opportunities employer. #J-18808-Ljbffr

OverviewSenior Medical Director, Haem-Oncologyat Kyowa Kirin International plcMarlow, UK (hybrid)WE PUSH THE BOUNDARIES OF MEDICINE.LEAPING FORWARD TO MAKE PEOPLE SMILEAt Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.Job Purpose:You will be the primary lead for Acute Myeloid Leukaemia (AML) and will provide strategic medical leadership and expertise for AML programmes across the KKI region working closely with global colleagues. The role will play a key part in driving the company’s AML programme through medical affairs leadership, cross-functional collaboration, and active support for clinical trial delivery in partnership with Clinical DevelopmentResponsibilitiesKey Responsibilities:Provide medical and scientific leadership for medical affairs AML programmes across the EMEA regionDevelopment and implementation of the regional pre-launch medical strategy in line with the global strategy for the company’s AML medicineServe as a subject matter expert in AML, offering consultation and guidance to internal teams and external partnersAct as the primary point of contact to address scientific enquiries and deliver presentations on disease stateCollaborate closely with global functions such as Medical, HEOR, Clinical Development and Clinical OperationsDevelop and lead the execution medical education programs related to AML for internal staff (Clinical staff project teams), and external stakeholders (Investigators, KEE’s, external CROs)Regional lead for all external regional company activities at all relevant haematology-oncology related events (congresses, conferences, etc.)Represent the Medical Affairs function in all relevant cross-functional project teams, business development activities and external engagementsSit on KKI Medical Affairs Leadership TeamQualificationsPosition Requirements:Qualified Physician (MD) required; with specialisation in Haematology and/or Oncology preferredSignificant experience in haematology or oncology, preferably with AML expertise, in clinical development, medical affairs, or related pharmaceutical industry roles within the EMEA region, with a strong preference for an established network of key external experts in the EMEA region in AMLDemonstrated expertise in the design, execution, and oversight of haematology or oncology clinical trials, including experience with regulatory requirements and safety monitoringProven ability to work effectively in cross-functional, matrixed teamsStrong leadership, communication, and presentation skills, with fluency in English (additional EMEA languages an advantage)Ability to work independently in a remote environment and travel as required (average ~35%, with potential for periods up to 50%)Kyowa Kirin International is an equal opportunities employer.No agencies please. #J-18808-Ljbffr

Your new company Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. My client, a leading legal firm with a presence across the UK, is looking for a qualified Tax Manager to join them to manage all aspects of the Firm's tax affairs. They have an excellent hybrid working policy, with only one day in the office, along with flexible working hours to suit personal circumstances. You will be supported by one direct report and take ownership of tax compliance, reporting and governance, while providing proactive tax advisory support to the business. This is an in-house role, not client-facing. Your new role You will: • Manage an array of tax responsibilities across partnership tax, self assessment, corporation tax for UK entities, VAT, employment and payroll taxes with some exposure to international tax and transfer pricing., • Prepare tax analysis and supporting schedules for year-end statutory accounts, including current and deferred tax calculations., • Support the team in managing the Firm's overall effective tax rate and forecasting tax cash payments., • Liaise with external tax advisers where required and manage associated deliverables., • International taxes; oversee the tax filing requirements for the international jurisdictions and assess the recoverability of those taxes in the UK., • Monitor of transfer pricing arrangements and any other group tax matters, • Oversee the preparation of the UK VAT returns, ensuring appropriate VAT treatments are applied, • Support with employment taxes, including PSA calculations, benefits in kind, PAYE and IR35., • Support the development and enhancement of internal tax processes, controls, and governance frameworks., • Provide tax advice on business initiatives and operational queries. What you'll need to succeed You will be a qualified tax professional, CTA, ACA, ACCA or equivalent and have a minimum of 5 years experience in a UK mixed tax environment. In-house tax experience would be a bonus. However, demonstrable experience in professional services is highly desirable. A strong understanding of UK partnership tax, VAT and employment taxes, experience of CCH and/or IRIS would be beneficial, along with strong Excel skills. What you'll get in return You will receive a salary dependent on experience up to £80,000 per annum. An excellent hybrid working policy of 1 day a week in the office, along with flexible working patterns are a leading benefit. An excellent and industry leading benefits package is available, including private medical cover, life assurance, income protection, critical illness, discounted gym membership and more (full list on application). What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV , or call me now on If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career. xrnqpay Hays Specialist Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be

A global pharmaceutical company based in Marlow is seeking a Senior Medical Director for Haem-Oncology. This role involves leading medical affairs for Acute Myeloid Leukaemia (AML), providing scientific leadership, and collaborating with cross-functional teams.

A leading global pharmaceutical company based in Marlow is seeking a Senior Medical Director for Haem-Oncology.The role involves providing strategic medical leadership for Acute Myeloid Leukaemia (AML) programs, driving the company's medical affairs leadership, and collaborating closely with global

Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office. Head of Managed Access Program Delivery, Medical Communities. Based in the UCB office in Brussels, Belgium, part of the Medical Affairs team.

Line management of team of Senior Regulatory / Regulatory Affairs managers. Primary RA interface with Europe Market Access and Medical Affairs for early touch points and represent RA in Area Brand Team (ABT) as applicable to provide strategic input for regulatory approval, ensure the business needs