Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)
PAREXEL
Overview
As a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance. Your work supports variations, renewals, and market expansions, delivering timely regulatory assessments and risk mitigation. This role offers remote options in several European locations and partners closely with cross-functional teams to make a patient impact.
Responsabilità
- Develop post-approval CMC submission strategies for variations, renewals, market expansions, and annual reports
- Assess regulatory impact of quality changes in production and QC
- Review study reports for regulatory compliance with requirements
- Coordinate submission preparation with manufacturing, supply chain, quality control, QA, and local/regulatory teams
- Write/review submission content aligned with regulatory expectations, including health authority inquiries
- Manage Regulatory Information Management systems to maintain worldwide submissions
- Identify, escalate, and mitigate regulatory risks
- Prepare regulatory documentation for registration files or variations (CMC/technical)
Requisiti fondamentali
- University-level education, preferably Life Sciences, or equivalent by experience
- Experience in regulatory affairs related to technical/CMC/quality in pharma
- Strong understanding of CMC and post-approval regulatory requirements
- Experience writing CMC sections of regulatory documents
- Knowledge of biological or vaccine processes
- Background in validation/Quality Assurance/production with regulatory documentation experience
- Understanding of qualification/validation principles
- Proficiency with Word, PowerPoint, Excel; experience with Veeva Vault valued
- Team spirit
- Flexibility
- Accountability
- CMC knowledge
- Post-approval regulatory requirements
- Regulatory submissions for variations/renewals
Offerta di lavoro pubblicata 3 giorni fa
Offerte di lavoro simili
- ...this role you will support worldwide post-approval regulatory activities focused on CMC for vaccines or biological products. You will work within a regulatory team... ...or equivalent Experience in regulatory affairs, especially technical/CMC/quality in pharma Strong...Home officeOrario flessibile
- Overview In this role you will lead and optimize the Quality Management System to ensure GMP, FDA and EU compliance across the site. You will partner with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report...SeniorRemotoOrario flessibile
- ...for gene editing and nucleic acid-based therapeutics within the GRD CMC team. You lead method development and... ...data quality, and contribute to regulatory documentation. This position offers... ...fondamentali ~ MSc in biotechnology, biology, biochemistry or related field ~5...SeniorStage/TirocinioRemoto
- ...implementation. This is a remote, Italy-based position within Parexel FSP, offering the... ...and close-out to ensure protocol and regulatory compliance Coordinate information flow... ...research ( Oncology preferred) Oncology, Vaccines, Internal Medicine or Infectious...SeniorRemoto
- ...Overview As Senior Process Scientist, you will drive the development... ...oversight of LNP-based gene therapy programs within Chiesi... ...external CROs/CDMOs and internal CMC teams to advance candidates from... ..., ensure quality and regulatory readiness, and guide lifecycle...Senior
40.000 € - 57.000 €
...stakeholder impact. Retribuzione / Benefits base salary range 40.000–57.000 EUR bonus/incentive pay company car home office allowance Responsabilità Coordinate... ...Bachelor's Degree in Chemistry, Biology or related Science Ability to analyze, facilitate...Home officeTempo determinatoAuto aziendaleRemotoTurno di notte- pA.I.TEC cerca un Tecnico Assistenza Automotive Senior con solida esperienza in officina per guidare l’assistenza tecnica e la diagnosi da remoto. Collaborerà con la Direzione Tecnica e sarà punto di riferimento per il team interno e le officine supportate da A.I.TEC....SeniorRemoto
- ...The Wind Energy division of Crrc Zhuzhou Institute Co., Ltd. seeks a Senior Business Manager to drive market expansion in Italy. This fully remote, field-based role requires based in Milan with regional travel to Sassari and other markets, focusing on client development...SeniorRemoto
- ...in computer science, statistics, algorithms, and genomics Experience developing novel but practical computational methods for biological challenges Expertise in NGS technologies and secondary analysis (mapping, alignment, variant calling) Strong software development...SeniorOrario flessibile
- ...and deploy the open-source hydrological model LISFLOOD and its associated data processing tools. /li liImprove model input/output processes... ...modelling capabilities. /li liDevelop machine learning-based surrogates and neural network approaches for parameter estimation...Senior
- ...Hire Feed is seeking a Senior Backend Engineer to design, implement, and maintain scalable backend systems supporting high-performance... ...-functional teams to deliver robust solutions for a global user base. The role emphasizes modern architectures, clean code, and DevOps...SeniorRemoto
- pGuidoio, la prima autoscuola online in Italia, cerca un Senior Backend Developer per guidare l’esecuzione tecnica e coordinare un piccolo... ...: remoto con ufficio a Milano, sviluppo in un ecosistema AI-based (Claude Code incluso) per trasformare l’esperienza di patente in...SeniorLavoro ibridoRemoto
- Overview In questa posizione arrotondata in Area Tecnica/Digital Infrastructure verrai chiamato a guidare la definizione di strategie cloud per i clienti, con focus su ambienti AWS o Azure. Progetterai architetture multiservizio, orchestrando migrazioni complesse e ...SeniorSmart workingOrario flessibile
- ...specializzato nell’assistenza tecnica e nella diagnosi. /ppPer il potenziamento del nostro team ricerchiamo un bTecnico Assistenza Automotive Senior /b, con una solida esperienza maturata in officina, da inserire in un ruolo di responsabilità nell’ambito dell’assistenza tecnica e...SeniorRemoto
- ppThis is a fully remote field-based role with no daily office attendance required. You will be based in b(Milan, Italy) /b and take charge of local... ...in market expansion-related work. /li /ulp(Wind Energy) Senior Business Manager sassari, sardegna, it /p /p #J-18808-...SeniorRemoto
- Overview In questa posizione, ti occupi di gestire le attività regolatorie per dispositivi medici a livello nazionale ed internazionale, garantendo conformità normativa, sottomissioni e manutenção delle registrazioni. Lavorerai a stretto contatto con sedi estere, distributori...
- ...market for a global EV charging software leader, building pipeline and closing six-to-seven-figure enterprise deals. You will work with senior leadership and cross-functional teams to win complex opportunities and accelerate Europe-wide expansion. This is a highly...SeniorRemoto
- Overview In this role you will lead customer engagement for ABB's sub-transmission portfolio (72.5–145 kV DTB), bridging product management and sales. You will shape go-to-market plans, drive market expansion in the US, and ensure SF6-free, digital-ready solutions meet...SeniorRemoto
- ...align R&D and commercial goals, shape trial designs, and drive regulatory success with high scientific and operational impact. You thrive... ...Diseases in line with R&D and commercial objectives Serve as senior clinical representative in global cross-functional governance...SeniorRemotoOrario flessibile
- Overview In questo ruolo puoi guidare lo sviluppo di soluzioni ML e DL end-to-end all'interno di un laboratorio di intelligenza artificiale. Lavorerai in un team multidisciplinare che integra ricerca, engineering e delivery per trasformare l'innovazione in risultati...SeniorLavoro ibridoRemoto
- Overview In this role you coordinate the operational management of assigned clinical projects to advance Chiesi's pipeline in line with medical standards. You act as the primary liaison to CROs, providers, and internal stakeholders, ensuring study quality, timelines...SeniorRemoto
- ...Overview In this role you lead the Product Compliance test laboratory in Italy, ensuring ICT hardware meets regulatory and standards requirements. You will manage lab operations and work with standardization bodies to develop and apply compliance standards. You'll...Lavoro ibridoOrario flessibile
- pAdecco Italia Spa cerca un Dottore Commercialista per uno studio in zona Castel Goffredo. La figura, inserita in un ufficio contabile strutturato, si occuperà di consulenza amministrativa, contabile e fiscale, confrontandosi direttamente con i clienti e operando attivamente...Senior
- La Scuola di Alta Formazione San Giuseppe Moscati cerca un Legale Interno per presidiare la compliance aziendale e la gestione contrattuale, con focus su privacy e normative di settore. Collaborerai con tutte le funzioni aziendali, verificherai la conformità contrattuale...
- ...Overview In this senior regulatory role, you provide strategic legal guidance across the lifecycle of Illumina's medical devices, diagnostics... ...strategies, and post-market obligations with Regulatory Affairs and Quality Advise on regulatory considerations for hardware...Orario flessibile
- Overview In questo ruolo creerai e manterrai un framework di conformità per garantire l'allineamento alle normative ICT e di Cybersecurity. Lavorerai all'interno del team Strategy Governance per supportare DPO/CISO/ICT Manager, definire strategie aziendali e piani evolutivi...Part-timeRemotoOrario flessibile
- Overview In this role you will lead the design vision for Deel's AI vertical, shaping AI-powered experiences across Deel's platform. You'll own end-to-end design strategy for Deel AI, Akai, conversational interfaces, agents, and developer tools, spanning in-chat flows...SeniorRemotoOrario flessibile
- ...Overview As a Senior Full Stack Engineer at Deel, you design, build, and maintain front-end and back-end systems that power Deel's global payroll platform. You collaborate with Product, Design, and DevOps to deliver scalable, secure solutions for a diverse, worldwide...SeniorTempo pienoRemotoOrario flessibile
- ...attenzione a tolleranze ristrette e finitura di alto livello. /ppRichiesta esperienza 5-10 anni, capacità di interpretare disegni tecnici e buona conoscenza di Microsoft Office; disponibilità a domicilio vicino all’azienda; contratto a tempo indeterminato. /p #J-18808-LjbffrSeniorImpiego permanente
- ...SaaS environment. Retribuzione / Benefits Stock grant opportunities Flexible office membership (IWG) Total rewards program Healthcare and benefits Competitive base salary Remote-friendly with inclusive policies Responsabilità Collaborate in a...SeniorRemotoOrario flessibile