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
- ...Unipol Assicurazioni S.p.A. cerca un Senior Specialist | Corporate Governance & Organi di Controllo da inserire nella Direzione Corporate Affairs, sede Bologna, in status di lavoro in sede. Il ruolo prevede gestione delle sedute dei Collegi Sindacali, verbalizzazione...Senior
- ...Unipol Assicurazioni S.p.A., leader nel settore, cerca un Senior Specialist | Corporate Governance & Organi di Controllo da inserire nel contesto della Direzione Corporate Affairs, con sede a Bologna e modalità di lavoro in sede. Il profilo richiede laurea magistrale...Senior
- 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
- ...Unipol Assicurazioni S.p.A., leader in Italia nei rami Danni, cerca un Senior Specialist per Corporate Governance & Organi di Controllo da inserire in sede a Bologna. Il profilo richiede esperienza consolidata in Corporate Governance presso contesti quotati e non quotati...Senior
44.000 €
...anni, maturata in ambito consulenza, compliance, risk management, audit o advisory, con possibilità di inserimento come Senior Consultant o Manager in base alla seniority; /li /brliConoscenza dei principali principi di risk management, controllo dei processi e compliance...SeniorSmart working- PwC Italy cerca professionisti con esperienza in governance, risk management e compliance per rinforzare i team IA&GRC. Ruolo orientato a supportare clienti nazionali e internazionali su modelli di controllo, antibribery e anti-trust, con focus su miglioramento dei processi...Senior
32.000 €
.../p pbSCS /bè alla ricerca, di una figura senior in ambito compliance, risk management e audit... .../li liOttima conoscenza del bpacchetto Office /b, in particolare bPowerPoint /b e... ...lavoro: ibrida, 60% sede - 40% smart su base settimanale. /b /p pPer la presente posizione...SeniorSmart workingLavoro ibridoOrario flessibile- ...KLK EMMERICH GmbH is seeking a Senior Regulatory Affairs Expert to lead regulatory systems development and ensure European compliance across the product lifecycle. You will liaise with authorities and cross-functional teams across Europe, including Italy, to drive REACH...Senior
33.000 €
...continents. The position of Field Service Engineer (m/f/d) is home office based, preferably around Bologna . Good travel connections, as... ...Qualifications Qualification in Electronic Engineering, Biology or Biotechnology or Bio-Chemistry or similar level of knowledge...Home officeImpiego permanenteRemoto- ...Bruker in Italy seeks a Field Service Engineer (m/f/d) with home office based work, preferably near Bologna, and significant travel to customer sites across Italy and Europe. You will install, commission and train customers on microbiology and diagnostic products and provide...Home officeRemotoLavoro da casa
- ...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
- ...in Oncology (TRIO) in Italy is seeking a Senior Clinical Research Associate to join our Monitoring Resources team. The role is home-based in Italy and reports to a CRA Line... ...You will conduct site visits, ensure regulatory compliance, and mentor junior CRAs. Fluency...SeniorRemotoLavoro da casaOrario flessibile
- ...Translational Research in Oncology) is seeking a Senior Clinical Research Associate to join our Monitoring Resources team. The role is home-based in Italy, reporting to a CRA Line... ...responsibilities spanning site visits, regulatory compliance, data verification, and...SeniorRemotoLavoro da casaOrario flessibile
- ...Research in Oncology (TRIO) is seeking a Senior Clinical Research Associate to join the Monitoring Resources team. This home-based role in Italy requires extensive oncology... .... You will conduct site visits, ensure regulatory compliance, and mentor junior CRAs while supporting...SeniorRemotoLavoro da casa
- ...consistent expansion into new resource-based production areas. KLK is committed to... ...of the company on a daily basis. Senior Regulatory Affairs Expert (f/m/d) Mission And... ...of contact for authorities, industry associations, service providers, and internal stakeholders...SeniorPermesso di lavoro
- ...Pentasia is seeking a Senior Technical Compliance Manager — Europe to own the European technical compliance function for an iGaming testing lab. The role is full-time and remote, with location options in Italy or Bulgaria, and travel within Europe as needed. You will...SeniorTempo pienoRemoto
18.808 €
...Senior Technical Compliance Manager — Europe Italy or Bulgaria | Full-time, Remote. The Role I am supporting a growing... ...Ideally 7+ years in technical compliance, certification, regulatory affairs or a test laboratory environment within online gaming, with meaningful...SeniorTempo pienoRemoto- ...specializzato in cybersecurity, fondato nel 2021, con oltre 1200 dipendenti e sedi in 10 paesi. Stiamo potenziando il team Enterprise con un Senior Java Developer / Technical Analyst per progettare e integrare soluzioni basate su architetture a microservizi. /ppLa risorsa sarà...Senior
- pIconsulting cerca un Senior Legal Compliance per Casalecchio di Reno. Il ruolo mantiene e evolve il sistema di compliance, coordina audit interni/esterni e garantisce allineamento a normative internazionali. /ppSi collabora con Legal, HR, IT Security e Operations, promuovendo...SeniorImpiego permanenteLavoro ibrido
- pOncode Srl cerca un Senior Full Stack Developer per la sede di Bologna, con esperienza in progettazione e programmazione software e capacità di seguire progetti dall'idea alla messa in produzione. Il ruolo prevede lavoro in team, interfacciarsi con i clienti e gestire...SeniorSmart workingImpiego permanenteRemotoOrario flessibile
- ...around 80% of the time to visit customers, with the ideal location in North-East Italy (Bologna, Modena, Bergamo, Venezia). A home-office base is supported alongside on-site service. You will diagnose, repair and service equipment, ensuring safety, quality and...Home office
20.000 € - 35.000 €
...manufacturing of cosmetic products. We are looking for a Regulatory Affairs Specialist to manage our Regulatory Affairs function... ...for our clients. The position will be based at our new operational office in the Meridiana district of Casalecchio di Reno , with...Stage/Tirocinio- ...Cosmoderma Commerciale S.r.l. is seeking a Regulatory Affairs Specialist to lead regulatory documentation for cosmetic products developed... ..., ensuring compliance across markets. The role is based at the new office in the Meridiana district of Casalecchio di Reno, with...
- pDevup Srl cerca una figura nel team tecnico per attività di consulenza HSE e implementazione di sistemi di gestione. Sarai coinvolto in analisi di rischi, redazione DVR e procedure, e nell’assicurare la conformità normativa presso i clienti, guidando progetti di miglioramento...Senior
- ...Zanichelli Editore S.p.A. cerca un Senior Data Engineer per l’unità Data Engineering del team Dati & IA. La figura guiderà la modernizzazione della piattaforma dati, l’integrazione di osservabilità, MLOps sui modelli LLM e ML in produzione, garantendo affidabilità, qualità...SeniorSmart working
- Un incubatore d'impresa a Bologna cerca un Consulente Senior Marketing e Comunicazione per supportare il progetto ECOSISTER. La figura si occuperà di promozione, strategia di lead generation e organizzazione di eventi. Richiesta laurea in comunicazione o marketing, almeno...SeniorSmart workingContratto con partita IVA
- ...Wolters Kluwer Italia cerca un Sales Representative nel team della divisione Legal & Regulatory. L'obiettivo è gestire la vendita di software applicativi dedicati agli studi notarili, inserendosi in un contesto multinazionale dinamico. Il candidato ideale ha laurea...Senior
- pCPL CONCORDIA cerca un progettista meccanico piping da inserire in un team di tecnici per la progettazione di impianti di trattamento gas, calore e GNL. Verrà coinvolto in modellazione 3D avanzata, predisposizione layout di offerta e redazione della documentazione esecutiva...SeniorSmart workingPart-time