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argenx SE
Gent, Oost-Vlaanderen, Belgium
Head of Post-Marketing CMC Regulatory page is loaded Head of Post-Marketing CMC Regulatory Apply locations Gent time type Full time posted on Posted 11 Days Ago job requisition id REQ-2516 Key Accountabilities and Responsibilities: Leads the CMC Regulatory Affairs function within post-marketing CMC. Pr
Source d'emploi : argenx SEargenx SE
Gent, Oost-Vlaanderen, Belgium
Senior Director BIS G&A/CMC page is loaded Senior Director BIS G&A/CMC Apply locations Gent Boston time type Full time posted on Posted 30+ Days Ago job requisition id REQ-2081 For the expansion of our BIS team, argenx is looking for a Senior Director BIS G&A/CMC. The Senior Director BIS G&A
Source d'emploi : argenx SEargenx SE
Gent, Oost-Vlaanderen, Belgium
Head of Regulatory Affairs EMEA page is loaded Head of Regulatory Affairs EMEA Apply locations Gent time type Full time posted on Posted 2 Days Ago job requisition id REQ-2548 For the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA. PURPOSE OF THE ROLE Th
Source d'emploi : argenx SEBioLizard
Gent, Oost-Vlaanderen, Belgium
1 Head of Sales & MarketingWho are we?BioLizard is an innovative leader in the field of bioinformatics, data analytics and AI, renowned for its commitment to excellence, focus on collaboration, and forward-thinking ethos. We are seeking a Head of Sales & Marketing who embodies our values and can serve as an ambassador for our brand in all internal
Source d'emploi : BioLizardLansweeper NV
Merelbeke, Oost-Vlaanderen, Belgium
Lansweeper provides a unique Technology Asset Intelligence platform for businesses to better understand, manage and protect their technology estate and network. Lansweeper helps customers minimize risks and optimize their technology investments by providing actionable insight into their technology estate at all times, offering trustworthy, valuable
Source d'emploi : Lansweeper NVSynergie Belgium
Zelzate, Oost-Vlaanderen
Bedrijfsomschrijving Producent van hoogwaardige basischemicaliën en speciale toepassingen. Als betrouwbare partner, leveren we innovatieve basismaterialen aan de meest diverse industrieën wereldwijd en verbeteren we de pr oductiviteit van onze klanten met goederen van topkwaliteit. Als leider in technologie en innov atie ontwikkelen we oplossinge
Source d'emploi : Synergie Belgiumargenx SE
Gent, Oost-Vlaanderen, Belgium
Senior Director BIS Quality page is loaded Senior Director BIS Quality Apply locations Gent Boston time type Full time posted on Posted 30+ Days Ago job requisition id REQ-2082 As argenx continues to grow and evolve, we are looking for a Senior Director BIS Quality. The Senior Director BIS Qua
Source d'emploi : argenx SEAqtor
Oostakker, Oost-Vlaanderen, Belgium
Wil jij ook mee het verschil maken in het leven onze patiënten? Aqtor! is gespecialiseerd in het aanmeten, fabriceren en afleveren van orthopedische hulpmiddelen. Onze missie is mensen met mobiliteitsbeperkingen in staat stellen om hun vrijheid terug te winnen. Wij streven naar innovatieve oplossingen die garanderen dat ieder individu zoveel moge
Source d'emploi : Aqtor, Oost-Vlaanderen, Belgium
€ 100.000 - 125.000
The company is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. The unique SIMPLE Antibody platform and suite of Fc engineering technologies combined with the complementary expertise of the people enabled them to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.
KEY ACCOUNTABILITIES AND RESPONSIBILITIES:
Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to support the company’s portfolio marketed products for local and global filings. The candidate will be responsible for assuring development and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out to other territories world-wide. Critical to this role are strong CMC regulatory strategy and leadership skills.
Lead the global post-marketing CMC strategy and CMC regulatory team.
Provide CMC regulatory affairs leadership, oversight and strategy in support of company products, including but not limited to CMC regulatory strategies, regulatory requirements in global and regional markets, regulatory strategic development plans and risk assessments, and advice on Health Authority interactions.
Lead Global Health Authorities interaction preparations on CMC strategy topics.
Provide guidance on the scientific/technical requirements for CMC and GMP related submissions to pending BLAs, MAAs and Life Cycle Management activities (annual reporting, variation planning and filing, change impact assessment).
Ensure post-marketing commitments strategy, follow-up and submission activities are planned and executed;
Review CMC and GMP related submission documents to assure compliance with regulatory standards and scientific/technical requirements and ensure their appropriateness for use in global regulatory submissions.
Ensures global CMC regulatory intelligence is built and captured across global CMC regulatory requirements.
Performs risk analysis for determination of probability of success for strategic regulatory CMC decisions, approves appropriate level of risk and mitigation for significant issues as required.
Establishes strong cross-functional partnerships to ensure collaboration with key internal stakeholders (RA, CMC, Supply Chain, Quality), and external organizations (contract manufacturers, regional regulatory partners etc).
Ensures goals are met, processes are aligned to ensure efficiencies and to promote collaborative global cross-functional relationships.
Be proficient in the tools and systems needed for the function including and not limited to Veeva RIMS and Veeva Quality docs – continuously seeking efficiencies in using these
QUALIICATIONS:
In-depth knowledge of global CMC regulations for biologic compounds, as well as devices, and the Module 2/Module 3 eCTD requirements.
Combination product experience desired (Prefilled drug delivery systems, drug/device systems) is a plus.
Experience in the biologic life-cycle activities desired.
Comprehensive knowledge of biologic and drug development process, pharmaceutical technology, manufacturing processes, GMP and related issues.
Highly knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).
Strong proven hands-on CMC Regulatory Affairs experience and knowledge of CMC regulatory submission requirements for global filings (FDA and/or EMA, etc.) is required.
Strong understanding of pharmaceutical development, the regulatory environment, project management, and medical terminology.
Have a solution-oriented approach to problem solving;
Ability to work on complex projects and within cross-functional teams with minimal supervision
Proactive strategic thinker; Operationally minded
Strong analytical, problem solving, organizational and negotiation skills.
Strong collaborative inter-personal, communication, presentation and meeting leading skills.
Strong ability to work in a project-based environment and across cultural lines.
Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
15+ years of experience in the pharmaceutical/biotechnology industry, 10 of which are in CMC Regulatory Affairs.
8+ years Leadership/management of Regulatory CMC activities and demonstrated organizational/planning skills.
Master degree or PhD in biotechnology, pharmaceutical sciences, biological science
Please submit your CV through the form below and we will contact you shortly.
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Head of Post Marketing - CMC Regulatory emplois en , Oost-Vlaanderen, Belgium
ⓘ Une erreur inattendue s'est produite lors du traitement de votre demande.
Veuillez rafraîchir la page et réessayer.
Si le problème persiste, veuillez nous contacter avec votre problème.
Vous pouvez toujours gérer vos préférences et mettre à jour vos intérêts pour vous assurer de recevoir les opportunités les plus pertinentes.
Préparez-vous à découvrir votre prochaine grande opportunité.