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Reporting to the Head of Regulatory Affairs, this individual will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and of high quality.
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Serve as USMA Head of HIV Treatment in cross-functional meetings, representing the US perspective and needs in working groups with Clinical Development, Global Medical Affairs, US Commercial, US Government Affairs and Policy, US Public Affairs, US Regulatory, and US legal and compliance.
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5 + years of experience in global CMC regulatory affairs. Key responsibilities include leading the preparation and maintenance of CMC/quality sections for regulatory submissions, serving as the CMC regulatory representative on project teams, and providing regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product lifecycle.
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The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
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Minimum of 12 years legal experience in securities, corporate governance, corporate transactions, intellectual property and legal operations with exposure to biopharmaceutical industry and healthcare regulatory law.
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Director/Senior Director, Regulatory Medical Writing (Remote). Position Overview: The position, reporting to the Sr. Director, Head of Global Regulatory Portfolio Management, with a dotted line reporting to the Interim Head of Medical Writing, will be the medical writing lead for clinical regulatory documents.
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This lead medical writer will lead submissions and oversee the selection and management of internal and contract medical/regulatory writers and organizations. This lead medical writer will lead submissions and oversee the selection and management of internal and contract medical/regulatory writers and organizations.
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A successful medical writer will be able to write independently and work effectively with cross-functional colleagues to develop documents efficiently and with high quality.
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A successful medical writer will be able to write independently and work effectively with cross-functional colleagues to develop documents efficiently and with high quality.
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A successful medical writer will be able to write independently and work effectively with cross-functional colleagues to develop documents efficiently and with high quality.
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Represent Global Regulatory Affairs on the Global Artwork Team; help develop, review, and approve global package artwork in close collaboration with Supply Chain, Quality Assurance, and International Regulatory Affairs colleagues.
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Support in the preparation of the Regulatory Affairs department budget. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
$270,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below.
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We are seeking an innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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They are looking for a Senior Director of Regulatory Affairs, Ad/Promo to join their team to support the commercialization of their late-stage programs. Senior Director, Regulatory Affairs - Advertising and Promotion.
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Title: regulatory affairs Company: Parexel in San Mateo, CA
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