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Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals. Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China.
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This person will provide medical/scientific expert advice and guidance to key customers for ADC products & relevant therapeutic areas, including scientific exchange & professional development with key thought leaders/external experts and provides medical/scientific affairs support to the US commercial team.
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Our client is seeking a Principal Regulatory Affairs Specialist for their Pleasanton, CA location. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment.
$160,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Develop and submit all applicable EHS permits, Forms, and reports to EPA, Wastewater, Fire Department, and other regulatory agencies. Strong track record of submitting permits, working with regulatory agencies, leading and developing EHS programs, performing audits, JHA, and gap assessment.
$147,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and regulatory pharmaceutical marketing and manufacturing principles, practices, and their application.
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Advanced knowledge of industry, regulatory or Department of Energy/National Nuclear Security Administration (DOE/NNSA) complex codes, standards, and criteria pertinent to the particular engineering discipline.
$262,668 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables. Author and revise SOPs, deviations, CRs and LIRs. Areas of responsibility include but are not limited to testing samples for Appearance, pH, UV and water content, HPLC, ELISA, western blot and SDS-PAGE as needed.
$30 - $37 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with IT, security, and compliance teams to ensure the alignment of CDP initiatives with architectural standards, regulatory requirements, and data privacy regulations. Experience working with data warehouse solutions such as Amazon Redshift, Google BigQuery, Snowflake, etc.
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Regulatory Compliance: Ensure all benefit programs comply with governmental regulations and labor laws, including ERISA, FMLA, and HIPAA. Provide oversight for all required testing, audits, and SOX compliance.
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Licensed mental health professional as confirmed by state regulatory/licensing board (e.g.,RN, LCSW, LMFT, Psychologist, or LPCC) from the state of operation. Additional regulatory, contractual or local requirements may apply.
$74.39 an hourFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Stay updated on relevant regulations and guidelines in the cell therapy manufacturing industry, review and interpret regulatory requirements to ensure compliance in manufacturing processes Physical Requirements Up to 10% overnight travel required.
$190,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Serve as a point of contact within the medical and scientific affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant ADC products, to support their safe, effective and appropriate use.
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Assist facilities management team in ensuring required regulatory permits are acquired, required reports are submitted to regulatory agencies and any site permit conditions (e.g. recordkeeping, process safety management (PSM), stormwater, special waste, etc.
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Knowledge of regulatory requirements and safety standards related to pipeline construction. Conduct site visits to monitor progress and ensure compliance with design specifications, safety standards, and regulatory requirements.
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Federal regulations require the use of GLP for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA. These regulations require implementation of a robust quality management system to ensure the validity, integrity and reliability of data submitted for regulatory evaluation and EPA approval.
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regulatory affairs jobs Title: affairs specialist Company: Beigene in Pleasanton, CA
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