Head of Post-marketing Cmc Regulatory
Il y a 2 mois
Key Accountabilities and Responsibilities:
Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to support
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 argenx’ 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
**Qualifications**:
- 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 mínimal 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).
Experience
- 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.
Educational Qualifications
- Master degree or PhD in biotechnology, pharmaceutical sciences, biological science
**Offer**:
- A competitive salary package with extensive benefits
- Front seat in the development of therapeutic antibodies
- A work environment in a human-sized, dynamic and rapidly growing biotech company
- Reporting to global CMC management
- Location: global
LI-onsite
Nous avons d'autres emplois actuels liés à ce domaine que vous pouvez trouver ci-dessous
-
Head of Post-marketing Cmc Regulatory
il y a 6 jours
Gent, Flandre, Belgique Argenx Temps pleinKey Accountabilities and Responsibilities:Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to supportdevelopment and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out toother territories world-wide. Critical to this role are strong CMC regulatory strategy and...
-
Associate Cmc Regulatory Scientist
il y a 3 semaines
Gent, Belgique Ardena Temps plein**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...
-
Associate Cmc Regulatory Scientist
il y a 6 jours
Gent, Flandre, Belgique Ardena Temps pleinAbout usAs a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, Ardena is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated portfolio...
-
Head of Regulatory Affairs Emea
Il y a 2 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA. PURPOSE OF THE ROLE The Head of Regulatory Affairs, EMEA, is a key member of the global regulatory team as well as the EMEA Leadership Team (ELT). This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute...
-
Head of Regulatory Affairs Emea
il y a 6 jours
Gent, Flandre, Belgique Argenx Temps pleinFor the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA.PURPOSE OF THE ROLEThe Head of Regulatory Affairs, EMEA, is a key member of the global regulatory team as well as the EMEA Leadership Team (ELT). This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute to...
-
Associate CMC Regulatory Scientist
il y a 6 jours
Gent, Flandre, Belgique Ardena Temps pleinAbout our CompanyAs a prominent contract development and manufacturing organization (CDMO) in the pharmaceutical sector, Ardena is committed to aiding pharmaceutical companies, from emerging biotechs to major players, in advancing their valuable molecules to the market. Our dedication involves offering a comprehensive range of services covering drug...
-
Head of Marketing
il y a 2 semaines
Gent, Belgique Entourage Temps pleinEntourage is an integrated venture studio that builds and funds the next generation of B2B SaaS companies. We combine a Venture Studio (Entourage Studio) with a Venture Capital fund (Entourage Capital). To further our mission, we are in search of a Head of Marketing to steer product and general campaigns, with a flair for devising and executing events that...
-
Senior Scientist Cmc
il y a 2 semaines
Gent, Belgique Argenx Temps plein1. PURPOSE OF THE FUNCTION A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim of developing, producing and characterizing these differentiated antibody...
-
Senior Scientist CMC
il y a 6 jours
Gent, Flandre, Belgique Argenx Temps plein1. PURPOSE OF THE FUNCTIONA senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim of developing, producing and characterizing these differentiated antibody...
-
CMC Scientist
il y a 5 jours
Gent, Flandre, Belgique Argenx Temps pleinargenx is a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique SIMPLE AntibodyTM platform and suite of Fc engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from...
-
(Associate) Scientific Writer
il y a 1 semaine
Gent, Belgique Ardena Temps plein**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...
-
(Associate) Scientific Writer
il y a 1 semaine
Gent, Belgique Ardena Temps plein**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...
-
Cmc Scientist
il y a 6 jours
Gent, Belgique Argenx Temps pleinTo further strengthen our CMC team, we are looking for an experienced and motivated CMC scientist/ senior Scientist. The scientist/ senior scientist CMC will play a lead role supporting cell line development, drug substance (DS) manufacturing process development and analytical method development with external manufacturing partners (CMOs) to enable clinical...
-
Scientific Writer – CMC Drug Substance
il y a 6 jours
Gent, Flandre, Belgique Ardena Temps pleinAbout ArdenaArdena is a contract development and manufacturing organization (CDMO) focused on supporting pharmaceutical companies in bringing their molecules to the market. With a team of 500+ professionals operating across five sites in Europe, Ardena offers a comprehensive portfolio covering drug substance and drug product development, manufacturing,...
-
Cmc Project Manager
il y a 6 jours
Gent, Belgique Argenx Temps pleinReport to: CMC project management Leader Key Accountabilities and Responsibilities: - Responsible for achieving project goals, including timelines, budget, and scope. - Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between...
-
Associate Director/director Regulatory Affairs
Il y a 2 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, based in Europe, to support the rapid growth needed for successful commercialization. The role will report into the Global Head of Regulatory Affairs. Key Accountabilities and Responsibilities: The Associate Director/Director Regulatory Affairs...
-
Cmc Project Manager
il y a 6 jours
Gent, Flandre, Belgique Argenx Temps pleinReport to:CMC project management LeaderKey Accountabilities and Responsibilities: Responsible for achieving project goals, including timelines, budget, and scope. Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between...
-
Scientist Cmc Analytical Development
il y a 6 jours
Gent, Flandre, Belgique Argenx Temps pleinKey Accountabilities and Responsibilities:Contributes to the CMC development of pre‐clinical and clinical stage development programs in close collaboration with the CMC team members by:Drives the development and validation of analytical test methods for large molecules release and stability testing in accordance with the applicable regulatory...
-
(Senior) Scientist Cmc Analytical Development
Il y a 2 mois
Gent, Belgique Argenx Temps pleinKey Accountabilities and Responsibilities: Contributes to the CMC development of pre‐clinical and clinical stage development programs in close collaboration with the CMC team members by: - Drives the development and validation of analytical test methods for large molecules release and stability testing in accordance with the applicable regulatory...
-
Associate Director/director Regulatory Affairs
il y a 6 jours
Gent, Flandre, Belgique Argenx Temps pleinFor the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, based in Europe, to support the rapid growth needed for successful commercialization. The role will report into the Global Head of Regulatory Affairs.Key Accountabilities and Responsibilities:The Associate Director/Director Regulatory Affairs is...
