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Collaborate and work cross-functionally with Manufacturing, Regulatory Affairs, Assay Development, Finance, and Quality functions to ensure all activities are scheduled and executed on time in accordance with program timelines.
$225,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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High level of understanding of the drug discovery, development and regulatory process, including experience working directly on drug development project teams and Regulatory Authority interactions and submissions.
$382,140 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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The Sr. SMA/SMA will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain, Regulatory Affairs and Project Management. Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
$130,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines in support of investigational studies.
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Meta seeks a highly motivated and experienced team player to join our Competition and Regulatory team. Experience with a wide range of policymaking and regulatory bodies. Active membership in at least one US state bar and eligibility to obtain registered in-house counsel status (if required by the State Bar in the assigned work location.
$266,000 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Title: Vice President of Quality Assurance & Regulatory Affairs. Experience with FDA and EU MDR regulatory processes. Additionally, in this role you will coordinate and work with a number of outside regulatory consultants to implement Neptune’s regulatory strategy across its diverse product lines.
$325,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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We are currently seeking a Regulatory Affairs Associate Director/Director to join our growing regulatory team. 5 – 7 (Director)/ 7 – 9 (Associate Director) years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment.
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Collaborate and work closely with Quality Assurance, Regulatory Affairs, Analytical Development, Clinical Operations, Legal, and Process Development teams at Tempest. Author and review drug product modules for regulatory dossiers and other controlled documents.
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Licensed mental health professional as confirmed by state regulatory/licensing board (e.g., LCSW, MFT, RN, or LPCC) from the state of operation. Licensed mental health professional as confirmed by state regulatory/licensing board (e.g., LCSW, MFT, RN, or LPCC) from the state of operation.
$136,029.34 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Prepare and provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (, IB, DSUR, PSUR, regulatory responses)Participate or lead as needed the review and assessment of new opportunities and ESRs. Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In-depth understanding of CMC regulatory requirements and experience with compiling CMC sections for regulatory filings. This position collaborates closely with cross-functional team members, including analytical development, quality assurance, manufacturing and process development, regulatory and clinical operations.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Experience with writing and reviewing of CMC filings for regulatory submissions, including IND/IMPD, BLA, and/or MAA, is highly desirable. The individual in this role will be the analytical, technical, and quality operational subject matter expert (SME) for QC CMC writing, review and assist in Regulatory filings (ICH/Compendial/FDA and EMA.
$125,000 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Conducting hands-on management of risk assessments, penetration testing, and security audits to verify security effectiveness and regulatory compliance. Expertise in core cybersecurity domains such as Identity Access Management (IAM), Data Protection, and Vulnerability Management, with a specific focus on integration within the SAP landscape.
$263,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
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regulatory affairs jobs Title: regulatory specialist Company: Abbvie in Burlingame, CA
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