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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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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs. As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.
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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.
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Strong business acumen and ability to see the business drivers outside of Regulatory Affairs. Hands-on experience in preparing regulatory submissions during development and for marketing authorizations.
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The Position 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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As a Regulatory Affairs Specialist at Guerbet, you will collaborate closely with our Senior Regulatory team, engaging in critical meetings and interactions with the FDA to shape regulatory processes for both our existing and upcoming drug products.
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This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned, as well as for all verbal and written communications with OPDP/APLB reviewers.
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Bachelor or Master’s Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred) 2-3 years’ experience in the pharmaceutical industry with 1-2 of those years in regulatory affairs preferred.
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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 26 days ago - UpvoteDownvoteShare Job
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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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Regulatory Affairs Specialist. Author standard operating procedures pertinent to activities in regulatory affairs. 4 to 7 years of regulatory affairs experience in pharmaceutical industry.
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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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The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance.
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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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regulatory affairs jobs Title: regulatory affairs associate in Montgomery, NJ
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