with cGMP, regulatory requirements (FDA, EMA), and quality assurance practices in medical device, drug-device systems...
. Job Description Must have :- Exp with regulatory requirements, including FDA, EMA and MHRA regulations. Experience with MES, LES, QMS, CMMS, CTMS... processes and operational workflows. · Familiarity with regulatory requirements, including FDA, EMA and MHRA regulations...
, EMA, MHRA, and Health Canada Electronic Submission Gateways (ESG,), as well as prepare and file non-eCTD submissions..., Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system) Veeva Vault RIM, ESG Gateway, Syncplicity (EMA Gateway...
Authority inspections (FDA/EMA), and support the execution of corrective action plans. Apply risk management processes...
- and audio-recorded assessments. Program ecological momentary assessment (EMA) surveys, monitor incoming data, and maintain...
criteria Regulatory, CMC & R&D Workflow Support Review regulatory and CMC scenarios involving IND, NDA, BLA, EMA materials... biomedical research programs Familiarity with IND, NDA, BLA, EMA submissions, CMC documentation, clinical trial operations...
within the pharmaceutical industry In depth understanding of IPSE, PDA, FDA, GMP ISO, EMA, ICH guidelines experience working...
standards, FDA/EMA regulatory requirements, and internal SOPs. Support deviation investigations, root cause analysis...
documentation of all operations in alignment with SOPs and batch records. Ensure strict adherence to cGMP standards, FDA/EMA...
documentation of all operations in alignment with SOPs and batch records. Ensure strict adherence to cGMP standards, FDA/EMA...