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 2 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
- ...exciting oncology launch opportunity! Senior Medical Science Liaison Manager (F/M/X)... ...to support the expansion of its Medical Affairs organization in Italy and contribute to... ...international and cross-functional teams A home-based position with an attractive compensation...SeniorLavoro da casa
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- ...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
55.000 € - 65.000 €
...nell'ambito del CCNL Commercio e Terziario applicato dalla nostra società. Il posizionamento all'interno del range sarà definito in base alle competenze tecniche, all'esperienza specifica nel ruolo e agli esiti del processo di selezione, secondo criteri oggettivi e...SeniorLavoro ibridoRemoto- ...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
35.000 € - 47.000 €
...funzionale. /li liAttitudineallagestioneautonomadelleprioritàe allavoroincontestidinamici. /li liOttimaconoscenzadi Excel edellasuite MS Office. /li liItalianofluentee inglese moltobuono;unaterza lingua è unvantaggio. /li /ul h3Ulteriori informazioni /h3 ul liContratto a...SeniorSmart workingImpiego permanente- ...Guidoio ricerca un Senior Backend Developer con esperienza di coordinamento tecnico. Sarai punto di riferimento per planning, qualità e decisioni architetturali, guidando un piccolo team verso soluzioni scalabili. Utilizzerai strumenti AI come Claude Code nel flusso...SeniorRemoto
- ...ambiente collaborativo e orientato alla crescita formazione continua Responsabilità Partecipare alla progettazione tecnica in base ai requisiti funzionali Sviluppare e manutenere applicazioni web e client-server in ambiente Java Collaborare con sviluppatori...SeniorSmart working
- 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
- ...Role: Senior Financial Reporting Associate (Remote) Location: Remote (Work from Anywhere) Role Overview:... ...adherence to internal controls and regulatory requirements for financial reporting... ...Equal Opportunity Employer: We hire based on skills and expertise. All...SeniorTempo pienoRemoto
- ...TECNICO ASSISTENZA AUTOMOTIVE- SENIOR Assistenza tecnica e diagnosi da remoto Da oltre trent'anni A.I.TEC opera al fianco dei professionisti dell'automotive come Centro Tecnico di Eccellenza specializzato nell'assistenza tecnica e nella diagnosi. Per il potenziamento...SeniorRemoto
- ...strong asset ~ Strong presentation and communication skills ~ MS Office skills required ~ Fluent Italia, good English language skills... ...~ Self-efficiency and ability to work as an individual from home ~ Ability to work remotely from home office in terms of dedicated...Home officeRemotoLavoro da casa
- ...Role: Senior Physicist (Remote) Location: Remote (Work from Anywhere) Role Overview: We are hiring for one of our clients, seeking... ...apply. Key Responsibilities: Develop and refine physics-based models to address specific technical problems. Conduct simulations...SeniorTempo pienoRemoto
- Hired is recruiting for a Go Software Engineer to join a remote-friendly team building next-generation dialog agents. The role emphasizes collaboration with cross-functional teams to define, design, and deliver new features for education, entertainment, and Q&A systems...SeniorRemoto
- ...Arup is seeking a senior Talent Acquisition partner to lead end-to-end recruitment across Europe, partnering with business leaders to define roles and deliver strategic hiring solutions in a dynamic, values-driven environment. You will map talent, leverage labour market...Senior
- ...Role: Senior Corporate Accountant (Remote) Location: Remote (Work from Anywhere) Role... ...financial reporting, ensuring compliance with regulatory standards, and overseeing month-end and... ...Equal Opportunity Employer: We hire based on skills and expertise. All qualified...SeniorTempo pienoRemoto
- ...Fondato nel 2021 e con sedi in 11 paesi, il gruppo conta oggi più di 1200 dipendenti in tutto il mondo. Siamo alla ricerca di un Senior IT Project / Service Manager con esperienza nella gestione end-to-end di progetti IT complessi e servizi continuativi per clienti...SeniorRemoto
500 €/mese
Tipo di contratto: P.IVA (valutiamo ritenuta di prestazione occasionale per il periodo di prova) ABBIAMO I CALENDARI PIENI - CI SERVONO CLOSER HIGH-TICKET (B2B) I nostri Setter stanno lavorando a ritmi serrati e ci stanno riempiendo le agende. Abbiamo troppi appuntamenti...SeniorLavoro occasionaleContratto con partita IVARemoto- 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
- ...data across assigned zones. This role requires strong driving skills, technical awareness, and the ability to work independently while coordinating closely with field coordinators. Travel and extended assignments away from home (hotel-based work) are required....Tempo pienoLavoro da casa
- ...Role: Senior Operations Analyst - Google (Remote) Location: Remote (Work from Anywhere) Role Overview: We are hiring for one of... ...across multiple regions. Equal Opportunity Employer: We hire based on skills and expertise. All qualified candidates are welcome...SeniorRemoto
35.000 € - 47.000 €
...Attitudine alla gestione autonoma delle priorità e al lavoro in contesti dinamici. ~ Ottima conoscenza di Excel e della suite MS Office. ~ Italiano fluente e inglese molto buono; una terza lingua è un vantaggio. Informazioni aggiuntive Cosa offriamo?...SeniorSmart workingTempo pienoImpiego permanenteLavoro ibridoOrario flessibile- ...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
- ...to act as a trusted talent acquisition partner Strong direct sourcing and talent mapping capabilities Confidence working with senior stakeholders Analytical mindset with experience using recruitment metrics Communication Full-cycle recruitment Talent...Senior