(Genesis - T4) based in Braine. You will work with This role collaborates closely with development scientists, CMC...
collaboration with the product CMC Quality Leads and the vendors. When applicable, be sure that the Annual Product Stability... Regulatory Affairs and CMC Quality Leads for submission document requests Coordinate legalization/notarization of documents...
CMC (= Chemistry, Manufacturing & Controls) compliance of the plant processes with the regulatory filings Validation... is responsible for pursuing regulatory CMC compliance of the site practice versus the registration dossiers. This is achieved...
- Braine l'Alleud The Responsibilities Manages Non-clinical formulation activities related to the screening and CMC...
in leading internal audits/self-inspections. – Familiarity with regulatory submissions and CMC (Chemistry, Manufacturing...
CMC Quality Solutions Specialist Location: Brabant Wallon, Région wallonne, Belgique Job #27289 CMC Quality... (even if scientific ownership stays with the CMC Lead). Experience in GMP / QA processes (change control, deviations, QMS support...
of the CMC sections of regulatory submissions. Provide support in the evaluation of Temperature excursions for IMP...
, structure & coordinate the CMC projects portfolio in line with the Assets & Patient Supply strategic plans for (a) given... compound(s), managing the inter-connections across projects, ensure coordinated plannings & deliverables, the CMC resource...
and CMC Development/CTS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations...
CMC Quality Solutions Specialist Location: Braine-l'Alleud, Région wallonne, Belgique Job #27634 CMC Quality... Solutions Specialist Contracting - Brabant Wallon Your responsibilities: The role is transversal and supports CMC Quality...