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Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs and other local and headquarter departments to accomplish company goals. Report to a Director of Regulatory Affairs.
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Engages cross-functional colleagues within DTE and Commercial to ensure Medical Affairs is able to inform requirements needed for digital tools that will be used globally for Vertex. Job DescriptionThe Senior Director (Head) of Digital Medical Affairs and Analytics will have domain expertise and leadership experience in both Medical Affairs and Digital and lead the digital transformation within Medical Affairs serving as the end-to-end program lead for large-scale strategic programs of high business value.
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As an integral member of the team that will be tasked with product development, the Associate Director Regulatory Affairs will also serve as a subject matter expert (SME) for assigned development programs, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.
$150ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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This position oversees all legal and compliance matters of the company by advising management in various departments, identifying risks, and offering advice and alternatives to mitigate risks.
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This position is part of the Quality Assurance and Regulatory Affairs group located in Coralville, IA , USA and will be remote. Support a team responsible for worldwide submission activities, maintenance of approvals and global regulatory strategies, across multiple sites, in support of PMA, 510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post-market surveillance activities, etc.
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The Head of Corporate & Legal Affairs will report directly to the CEO, with whom Cornerstone has had over a decade-long relationship and is a well-respected, collaborative leader with a rich history of working for start-ups and well-established CROs.
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In-depth knowledge of Regulatory Affairs strategies with an executive level of experience in the biotechnology and pharmaceutical industry with a focus on rare/ultra-rare disease and orphan drug development and the 505(b)2 pathway.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Provide management and oversight of the Medical Affairs team which includes the US HEOR team, publication and scientific communication team, call center, Congress planning and KOL mapping and strategy.
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The Senior Director, Medical Affairs will be a leadership role, accountable for Medical Affairs strategy, Medical Excellence, and field team execution for Orchard's investigational and approved hematopoietic stem cell - gene therapy (HSC-GT) clinical programs in North America (NA.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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Ensure seamless coordination towards the drafting and advancement of effective federal legislation and regulations from BCBSMA to Congress and relevant federal agencies and ensure the coordinated flow of relevant legislative and regulatory information to the Vice President, State and Federal Government and Regulatory Affairs, and senior leaders including the Senior Vice President.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice-President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
$250Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We are seeking an Associate Director/Director of Regulatory Affairs to join the company. Bachelor's degree in Biological Sciences, Pharmacy or related field is required; Advanced degree or certificate in regulatory affairs is preferred.
$250ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Responsibilities:Provide administrative support to the Academic Affairs department. Knowledge of academic affairs processes and procedures is preferred. Responsibilities:Provide administrative support to the Academic Affairs department.
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Summary: Develop and manage the commercial distribution, commercial supply chain, and trade affairs for a new product launch at Apnimed. 10+ years relevant experience in pharmaceutical commercial distribution and trade affairs.
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The VP, Head of Medical Affairs, Oncology, will be a strategic partner for the assets under his/her responsibility, and will lead a dynamic US-based group overseeing the medical strategy and operational execution of all the multiple functions and therapeutic indications for all marketed products, products in development and provide expertise in business development, as required.
$270,000 - $396,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
Title: affairs Company: Turnstone Biologics in Waltham, MA
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