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
- Descrizione azienda Openjobmetis Spa, filiale di Ascoli Piceno, ricerca e seleziona la figura di Addetto/Addetta Regolatorio per importante azienda metalmeccanica di Ascoli Piceno. Posizione La figura di Addetto/a Regolatorio assicura che i prodotti e i materiali...ConsigliatoTempo pienoDal lunedì al venerdì
Openjobmetis Filiale di Ascoli Piceno
Ascoli Piceno (AP)14 giorni fa - ...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
- ...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
- ...A.I.TEC sta potenziando il team di assistenza tecnica con un Tecnico Assistenza Automotive Senior, operante in orbì di Orbassano (TO). Il candidato leader ha esperienza officina, gestione diagnostica e supervisione di attività complesse, lavorando in stretto contatto...SeniorRemoto
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 notte55.000 € - 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
- 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. Per il potenziamento del nostro team ricerchiamo un Tecnico Assistenza Automotive Senior , con una solida esperienza maturata in officina, da inserire in un ruolo di responsabilità nell’ambito dell’assistenza tecnica e...SeniorRemoto
- ...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
- ...Ruralis.com cerca un Senior Sales Development Representative per guidare l’acquisizione di nuovi proprietari nell’ecosistema Ruralis, lavorando in team e con i reparti aziendali. Ruolo full-time, modalità totalmente remota e 40 ore settimanali, dal lunedì al venerdì....SeniorTempo pienoRemoto40 h/sett.Dal lunedì al venerdì
- ...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
- ...specializzato nell’assistenza tecnica e nella diagnosi. /p pPer 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
- pClutch cerca un DevOps/Cloud Engineer per progettare, implementare e gestire un’infrastruttura cloud solida e scalabile per la nostra applicazione SaaS web. Farai parte di un team di esperti appassionati di cloud, Kubernetes e IaC, mirando massima disponibilità ed efficienza...SeniorRemoto
- ...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
- pOpenjobmetis Spa, filiale di Ascoli Piceno, seleziona un Addetto Regolatorio per una solida azienda metalmeccanica di Ascoli Piceno. La risorsa garantirà la conformità di prodotti e imballaggi secondo normative vigenti. /ppCollaborando con QA, Produzione, Ufficio Acquisti...
30.000 € - 35.000 €
ADENTIS Italia è alla ricerca di un Sistemista IT con consolidata esperienza nella gestione di infrastrutture enterprise, ambienti applicativi e servizi cloud. La risorsa sarà coinvolta in configurazione, manutenzione, monitoraggio e ottimizzazione di sistemi complessi...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
- ...Fluence Energy, LLC in Italy's Marche region seeks a Senior Portfolio Finance Manager to own contract administration, budgeting, and forecasting across infrastructure portfolios. You will collaborate with cross-functional teams to ensure compliance and transparent financial...Senior
- ...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 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...
- ...Openjobmetis SpA cerca per azienda nel settore stampaggio un Operatore/operatrice Controllo Qualità Produzione Senior, con forte orientamento ai risultati e spiccate doti di leadership. La risorsa pianificherà e gestirà il controllo qualità dei prodotti finiti, definendo...Senior
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 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
- Silversea is seeking a seasoned Pastry Chef to lead all pastry and bakery operations aboard its luxury vessels. You will supervise production for all meals and events, ensuring the highest quality, presentation, and guest satisfaction. Strong leadership and global pastry...Senior
Ricerche correlate
- compliance officer Ascoli Piceno (AP)
- rappresentante senior Ascoli Piceno (AP)
- senior data engineer Ascoli Piceno (AP)
- senior sales Ascoli Piceno (AP)
- tecnico senior Ascoli Piceno (AP)
- senior developer Ascoli Piceno (AP)
- senior marketing Ascoli Piceno (AP)
- consulente commerciale senior Ascoli Piceno (AP)
- senior manager Ascoli Piceno (AP)
- contratto consulente senior Ascoli Piceno (AP)