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We are seeking a Regulatory Affairs Manager to join our global team based in Hampshire, UK. The Regulatory Affairs Manager role offers you an exciting opportunity to join our highly motivated Product Development – Injectables team, a patient-centric, fast paced environment focused on rare diseases. This position operates within Alimera Sciences Limited, a subsidiary of ANI Pharmaceuticals, with a 3 day per week in office expectation. If you are a regulatory professional with European experience who is looking to expand and grow in their career, then this could be an excellent opportunity for your development! It is a global role, with a primary focus on our international (non-US) markets, which will provide opportunity for you to expand your international and US regulatory experience across a wide breadth of projects and submissions. The successful candidate will be responsible for leading regulatory activities for international projects, providing regulatory guidance and liaising with external partners including regulatory authorities. This role is a key member of a highly visible team and provides prominent exposure across multiple business units and with leadership. As a dynamic growing company, this role values accountability, adaptability and a proactive mindset to support the company’s expansion. TASKS / RESPONSIBILITIES • End to end management of complex global projects and submissions, from developing strategies through to the filing of applications and post-approval implementation., • Oversee and support licensing partners in international regions (including Middle East, Asia, Australia)., • Responsible for a range of submissions from initial authorisation applications, variations/supplements, annual reports through to clinical trials and educational materials., • Regulatory point of contact for key projects, collaborating closely with multiple cross-functional areas including PV, Quality, Manufacturing, Supply, Medical and Marketing., • Understand, interpret and advise on regulatory legislation and guidance., • Interact with regulatory authorities to facilitate successful submissions and approvals., • Author high quality Common Technical Dossier (CTD) modules and regulatory technical documents., • Input into cross-functional submission documents, e.g. clinical protocols, PSUR, DSUR, PADER, educational materials, quality/manufacturing reports., • Management of regulatory labelling texts, including coordination of translations. PROFESSIONAL QUALIFICATIONS/EXPERIENCE • Degree in life sciences, engineering, pharmacy or higher, • Minimum of 5 years experience in European Medicinal Regulatory Affairs., • Proven ability to accurately assess regulatory impact, develop effective strategies and deliver submissions. Prior experience with European MRP/DCP is required., • Excellent written and verbal communication skills in English., • Experienced at authoring regulatory technical and submission documents., • Proven track record with navigating post-approval CMC changes, including ability to identify regulatory impact, data requirements and achieve successful filings., • Sound performer in interacting with and influencing regulatory authorities., • Prior US medicinal regulatory affairs experience and familiarity with global regulations, including US, is beneficial but not required. Knowledge of medical devices and drug-led combination products is desirable. SKILLS AND COMPETENCIES • Effective and influential communicator – you have strong verbal and written skills, able to clearly convey regulatory positions and persuade internal and external stakeholders., • Broad knowledge of European regulatory systems, including relevant current and upcoming legislation, • You can understand and interpret regulatory legislation and guidance documents., • Self-motivated, self-reliant and able to work independently in a fast-paced, deadline driven environment., • Effective networker and team worker – you are able to build effective working relationships with colleagues, external partners and regulatory authorities., • Strong analytical thinking and problem-solving skills, with a high attention to detail. Proven ability to deliver well thought-through and evaluated solutions., • Sound project management and organizational skills – you are able to effectively plan time and prioritize to achieve goals., • Flexible approach – able and eager to learn new things, think creatively and laterally, and think outside the box. Willingness to roll up your sleeves and get things done.

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law. To characterise the companies biotherapeutic recombinant T-cell receptor based and related molecules using a wide variety of protein characterisation and mass spectrometry methods. To contribute to the development of characterisation methods for the company's biopharmaceutical products, including peptide mapping (LC-MS/MS) and intact mass spectrometry analysis. KEY RESPONSIBILITIES • Supporting drug substance and drug product impurity characterisation and identification, • Performing protein sequence and post translational modification identification, including glycosylation analysis., • Supporting drug substance and drug product process development by performing characterisation of process intermediates, • Contribute to the Development of characterisation methods of ImmTAX and other products, including peptide mapping (LC-MS/MS) and intact mass analysis, • Designing and carrying out biochemical characterisation, chemical stability and comparability studies of biologics/drug products., • Contribute to writing study protocols and reports., • Independently testing and, increasingly, leading lines of investigation. Proposing new experiments based on emerging data and other related information. Providing support on technical aspects to others., • Priorities: establishing priorities for own work and team-based projects; making decisions on prioritisation based on the overall goals of the team, department and project, using direct evidence and personal experience as guidance., • Technical Knowledge: sharing knowledge with the wider team and, across departments representing the department. May also act as a mentor to other colleagues, sharing scientific knowledge. Providing analysis of new techniques and theories from outside the Company to advance the way the company works; sharing these with leaders across the department., • Laboratory records: ensuring that all records and information are up to date, on time and recorded to the correct standard. Supporting and encouraging others to achieve this., • Laboratory equipment: providing technical guidance to others within the team on how to use equipment most effectively., • Reporting: communicating and presenting research findings at meetings with colleagues, senior management and partners., • Adhere to safe working practices in laboratories according to Immunocore EHS policies. PERSON SPECIFICATION Experience & knowledge Essential • Experience in development of HPLC based peptide mapping methods and mass spectrometric characterisation of recombinant proteins or antibodies., • Experience of glycosylation analysis of recombinant proteins or antibodies., • Independently coordinated extensive testing of protein biomolecules., • Experienced in the characterisation of proteins expressed in both microbial and mammalian systems., • Understanding of expected post-translational modifications in biological systems., • Worked in a bench-based biopharmaceutical laboratory environment., • Experienced in assay development, • Familiar with biopharmaceutical stability study principles and interpretation thereof, • Worked and contributed actively in a diverse team environment, • Proposed and driven changes in working practices that have improved efficiency, supported teams through adoption and change, • Presented detailed scientific findings and papers to internal and external audiences Desirable • Experience of glycosylation analysis of recombinant proteins or antibodies, • Experience with late stage/commercial biopharmaceutical assay development and characterisation, • Familiar with the principles of Good Manufacturing Practise (GMP), • Presented at external conferences, • Led a small project team, formally or informally, through a change in practice including project management, • Understanding of analytical requirements to support materials for use in clinical trials Education & qualifications • Essential: BSc. Or MSc. in biochemistry, biotechnology or related discipline, • Desirable: PhD in related discipline

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CMC Manager Location: Woking (Fully Site‑Based) Hours: 7:00am – 3:00pm, Mon-Fri Contract: Permanent About the Role We are seeking an experienced CMC Manager to lead the transition of new pharmaceutical products from early research through scale‑up and into GMP manufacturing. D

CMC Consulting is partnering with a leading UK manufacturing business experiencing exciting growth and seeking an analytically minded FP&A Analyst. CMC Consulting is committed to equal opportunities.

What we’re looking for: * A strong background transitioning from Scientist to CMC Technical Writer, with several years’ experience authoring high‑quality CMC submission documents or * An established Regulatory CMC professional with a significant focus on technical writing a

CMC Consulting is committed to equal opportunities.

CMC Consulting is committed to equal opportunities.

Strong understanding of CMC regulatory frameworks, quality systems, and manufacturing processes. If you are a detail‑driven Regulatory CMC specialist who thrives in a flexible freelance environment, we would love to hear from you. Regulatory CMC Technical Writer.

To act as the CMC Regulatory Lead on CMC Teams, representing the CMC Regulatory viewpoint and expertise on the CMC Team;. As a key member of the Regulatory Affairs CMC team, the candidate will have responsibility for developing CMC regulatory strategy for the clinical portfolio from a Regulatory CMC

Principal / Senior Regulatory Affairs CMC Consultant. As a Principal or Senior Regulatory Affairs CMC Consultant, you will play a key leadership role, providing high-level regulatory and technical guidance for complex therapeutics. Provide strategic, technical, and regulatory CMC advice to clients,

Extensive experience in CMC strategy and a minimum of ten years of experience in CMC development and regulatory compliance. Scendea is seeking a highly motivated individual to join our global team as a full-time Principal Consultant (CMC). Provide strategic, technical and regulatory advice/services

CMC Partners, part of the G&E Group, is a specialist Executive Search and Consulting firm working across the. At CMC Partners, you’ll benefit from:.

CMC Consulting is committed to equal opportunities.

A global pharmaceutical company seeks a CMC Regulatory Manager to lead post-approval regulatory strategies and ensure compliance for life-saving medicines.

A leading global professional services firm is seeking an experienced Associate Tax Director to support and lead a UK corporate tax team.In this role, you'll manage a portfolio of complex clients, oversee compliance and advisory matters, and contribute to the strategic direction of the department.Th

A leading healthcare organization in Greater London seeks a Band 8a Neonatal Nurse Specialist to provide expert clinical leadership for neonates with complex medical needs.The role involves acting as a primary resource for families, leading education and quality initiatives, and ensuring smooth tran

Provide strategic and regulatory advice on CMC aspects of drug development. Experience authoring CMC sections of regulatory submissions; MAA/BLA experience preferred.

Operating across multiple regulatory jurisdictions, CMC develops and delivers its own retail and B2B trading and investment platforms. CMC Markets is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of gender, sexual or

A leading pharmaceutical consulting firm in the UK is looking for a CMC Manager to lead the transition of new pharmaceutical products from research to GMP manufacturing.

A leading financial services provider in Greater London is seeking a Financial Risk Manager to enhance its Risk team.This role involves developing and monitoring risk metrics, daily stress testing, and reporting on financial risks.Candidates should have experience with derivatives and Python program

A biotech company in Greater London is seeking a Senior Manager for Regulatory Affairs CMC. The role involves planning and preparing CMC-related submissions for health authorities.

An established industry player is seeking a commercially focused qualified accountant to join their dynamic team.In this role, you will play a crucial part in driving margin and revenue growth by delivering comprehensive sales and margin performance reporting.Collaborating closely with the Director

Meet one of the first 25 applicants for this role at CMC Consulting Ltd.

Help shape a high‑ambition agenda: advance the global CMC brand, expand our multi‑asset experience, and meaningfully increase market visibility. CMC Markets is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of gen

The ideal candidate will have a strong background in regulatory submissions and CMC, with an emphasis on timely communication and compliance with UK and EU legislation.

Interim Finance Manager - Milton Keynes.My client is a high-performing business seeking an experienced Interim Finance Manager to take ownership of the day-to-day finance function during a key period of transition and growth.This is a hands-on role requiring a strong blend of technical accounting ex

A clinical-stage biopharmaceutical firm in the United Kingdom is seeking a Director, Regulatory Affairs CMC. This leadership role involves developing global CMC regulatory strategies for innovative therapies aimed at cancer treatment.

Our client is a leading international entertainment business.As the company continues to grow and evolve, they are seeking a practice-trained, qualified accountant to take ownership of its group finance function.Reporting directly to an accomplished finance leader, this role will offer broad respons

A leading executive search firm in Greater London is seeking ambitious graduates to join as Executive Search Consultants.The role focuses on delivering high-impact recruitment projects and includes comprehensive training and development opportunities.Ideal candidates demonstrate strong commercial aw

A leading global pharmaceutical firm is seeking a Regulatory Affairs Manager to oversee post-approval regulatory strategies and manage compliance for high-quality medicines.The role involves evaluating manufacturing changes, drafting regulatory documents, and collaborating with cross-functional team

A consulting firm in Milton Keynes seeks an experienced Interim Finance Manager for a 3-6 month hybrid working contract.The role focuses on day-to-day finance functions during a period of transition, requiring expertise in statutory accounting, VAT returns, and management reporting.Ideal candidates

A leading financial technology company seeks a Security Platform Engineering Manager to enhance its Platform Engineering capabilities.This role involves defining and operating reusable security capabilities for customer-facing services.The ideal candidate will have deep expertise in securing cloud n

Group Accountant – First Move from Practice.This role offers an excellent first move into industry for an ACA‑qualified (or recently qualified) accountant seeking exposure to commercial finance within a multi‑entity organisation.The position provides hands‑on involvement in core financial ac

Quantitative Researcher - Principal Specialist page is loaded## Quantitative Researcher - Principal Specialistlocations: Londontime type: Full timeposted on: Posted 3 Days Agojob requisition id: CMC4556Since launching in 1989, CMC Markets (CMC) has become one of the world's leading online fi

A leading financial trading platform in the UK is looking for a Quantitative Researcher - Principal Specialist.This role involves mentoring existing team members, developing pricing models for complex products, and collaborating with various teams to optimize risk management strategies.Qualified can

Direct message the job poster from CMC Consulting Ltd. CMC Consulting are partnered with a rapidly expanding multi-site leisure company who are recruiting a Management Accountant to support their Financial Controller during this exciting growth phase. For similar opportunities and the latest updates

A leading trading firm in the United Kingdom is seeking an experienced Information Security Manager to shape global security governance and risk frameworks.This senior role focuses on strategic oversight and regulatory alignment, requiring strong leadership and collaboration with teams across region

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A leading financial services firm in Greater London is seeking an experienced Senior Project Manager to lead large-scale change initiatives.This high-impact role requires overseeing complex, cross-functional programmes and managing the entire project lifecycle.The ideal candidate will possess strong