A company is looking for a Senior Regulatory Affairs CMC Associate. ...
The associate on Regulatory Reporting Controllers Team will play a key role in managing reporting that is materially accurate, complete, and timely for external data filings required to comply and fulfill regulatory, financial, external, and legal obligations which impact critical bank filings/submi...
A company is looking for a Senior Associate in US Regulatory Affairs. ...
Identify potential regulatory risks while responding to complaints, formulate recommendations and escalate internally, as needed. Work directly with state regulators to respond to complaints and resolve escalated regulatory complaint issues. Prepare trend and root cause analysis to identify potentia...
A company is looking for a Senior Associate Regulatory Affairs for a remote position. ...
Solid knowledge and experience related to FDA/Competent Authority inspection methodologies, FDA risk assessments, non-conformance interpretation/management, regulatory reporting requirements, and regulatory enforcement activities. Provide support within the Regulatory Inspection and Client Audits (R...
Identify potential regulatory risks while responding to complaints, formulate recommendations and escalate internally, as needed. Work directly with state regulators to respond to complaints and resolve escalated regulatory complaint issues. Prepare trend and root cause analysis to identify potentia...
Identify potential regulatory risks while responding to complaints, formulate recommendations and escalate internally, as needed. Work directly with state regulators to respond to complaints and resolve escalated regulatory complaint issues. Prepare trend and root cause analysis to identify potentia...
The Regulatory Compliance Specialist will partner with the Regulatory Compliance Managers to submit and process licenses, permits, Sara Title II, CA CERS and other regulatory reporting. This role will be a strategic partner by working closely with branch operational staff to ensure compliance with a...
A company is looking for a Senior Manager, Regulatory Affairs. Key Responsibilities:Lead creation and maintenance of Company Core Data Sheets (CCDS) activitiesDrive global implementation of CCDS into country-specific labelingFormulate and drive global technology initiatives for labeling and content ...
A company is looking for a Principal Regulatory Affairs Specialist for Digital Health Apps. ...
Key Responsibilities:Provide strategic and tactical regulatory guidance for in vitro diagnostics/companion diagnosticsDevelop regulatory strategies for product registration and study designsInteract with diagnostic partners and regulatory agencies for submissions and meetingsRequired Qualifications:...
Key Responsibilities:Focus on clinical regulatory filings and providing strategic and operational leadership on project teamsContribute to IND/CTA and BLA submissions activities for products in developmentDevelop regulatory strategies for assigned programs and communicate with regulatory agenciesReq...
A company is looking for a Senior Regulatory Compliance Specialist. ...
Key Responsibilities:Plan, lead, document, and report Security Risk Assessments focusing on information security and HIPAA complianceDevelop and maintain internal Policies & ProceduresEnforce compliance with Policies & Procedures, documenting instances of non-compliance and overseeing remediationReq...
A company is looking for a Regulatory Affairs Director - Global Regulatory Leader in General Medicine/Cardiovascular. ...
A company is looking for an IT Project Manager II. ...
A company is looking for a Customer Experience Lead Project Manager. ...
Key Responsibilities:Design and implement communication strategies to advance Operations objectivesOversee press release drafting, distribution, and internal review processesManage external communications agencies and budgets to support Operations communications strategyRequired Qualifications:High ...
A company is looking for a Security Compliance Analyst III. ...
A company is looking for a Governance, Risk and Compliance Specialist for a remote position. ...
A company is looking for a Senior Regulatory Implementation Program Manager. ...
A company is looking for a Regulatory Specialist - Dental Operations. Key Responsibilities:Support external and internal regulatory reporting, surveys, audits and investigations impacting dental operationsMonitor incoming regulations and share regulatory guidance with dental operationsPerform monito...