Fda Regulatory Subject Matter Expert Jobs

... processes to determine compliance with regulatory requirements, guidelines and established standard ... an emphasis on technical expertise, regulatory risk, and quality advice. GQ-QLP ... also responsible or coordination/management of..

... activities to ensure patient safety, regulatory requirements and improve its effectiveness ... Product Deviation Reports for the FDA or the equivalent notifications to ... Thorough understanding of cGMPs and..

... BiFi and Peperami.Job DescriptionThe Sr. Regulatory Affairs Specialist is responsible for ... interpret labeling regulations and communicate regulatory, labeling and compliance matters. Responsible ... government interactions pertaining to the..

... stakeholders. Serve as a cGMP consultant/subject matter expert, providing researched and fact-supported information ... including assessing whether response meets regulatory authority, local authority, and BioMarin ... with GxP Strategy..

... the Food & Drug Administration (FDA). The successful candidate may also ... the eGrants tool and the subject matter expert on BioMarinu2019s grants policies; Performing ... and promotional documents..

... (cGMPs), Food and Drug Administration (FDA) standards, relevant foreign drug regulatory standards, established specifications, and drug ... purview. She/he is recognized as subject matter expert in the principles and..

Job Description:Title: Sr. Audit Manager - Good Pharmacovigilance Practices (GVP) / Drug Safety Location: Remote Travel: Up to 40% domestic and internationalu00A0About BioMarinu00A0BioMarin is a leading biopharmaceutical company with over 25 ..

... will ensure compliance with global regulatory requirements, maintain/improve data quality, and ... from appropriate departments, functions, and Subject Matter Experts (SMEs) regarding information needed ... assurance, compliance, data management,..

... in quality;• Acts as a subject matter expert (SME) on quality compliance in ... support of corporate and plant FDA inspections and sit in with ... inspections and sit..

PRINCIPAL REGULATORY AFFAIRS SPECIALIST - CYBERSECURITY Transforming ... exciting role as a Principal Regulatory Affairs Specialist in Cybersecurity, you ... will develop and implement medical regulatory strategies to obtain timely..

... compliant with all relevant regulations (FDA, 13485, PMDA). Provide feedback to ... assessments to ensure quality and regulatory requirements are successfully implemented and ... and regulations and ensures that..

PURPOSE AND SCOPE:The Senior Ethics & Compliance Officer (SECO) will manage the compliance program for several product lines within the renal pharmaceutical and medical device divisions of Fresenius Medical Care North ..