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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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A demonstrated track record of successful business experience in other related functional areas, such as Health Care Compliance (HCC), Medical/Scientific Affairs, Sales, Marketing, Legal, etc. Johnson & Johnson is currently seeking an Associate Director, Regulatory Advertising & Promotion to join our Health Care Compliance organization located in Titusville, NJ. At Johnson & Johnson,we believe health is everything.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Johnson & Johnson is currently seeking an Associate Director, Regulatory Advertising & Promotion to join our Health Care Compliance organization located in Titusville, NJ. Identify issues and facts that may be impacted by and subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends; fraud and abuse laws and HCC policy); and helping to develop alternatives to avoid any misperception in the respective communication while achieving the desired communication outcome outcomes.
$135,000 - $232,300 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Affairs and is based in Morristown, New Jersey. Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs.
$60,000 - $90,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required.
$180,000 - $200,000 a yearExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Foster and facilitate communication with Global Regulatory Affairs on these topics, including mentoring of junior staff. Member of the Global Project Team to represent Regulatory Affairs for assigned projects/products.
$178,500 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidances, and company policies.
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The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met.
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Regulatory Affairs Labeling Associate Level – I is needed to support Client’ business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices.
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The Regulatory Affairs (RA) Associate is a key role of the Global RA Transition project who will assist with the coordination and/or completion of international document requests and support activities related to contracting and purchase orders.
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Associate Director, Regulatory Affairs Strategy. 9-11 years of experience in US Regulatory Affairs in development, life cycle and post marketing regulatory affairs and regulatory submissions for drugs preferably with specific experience in oncology.
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Support Client business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices. Applying strategic thinking, pharmaceutical educational knowledge, and regulatory intelligence during preparation and review.
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