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Role : Regulatory Affairs Associate. Direct interaction with RA functions including Regulatory Operations, Submissions Execution, Regulatory Project Management, Strategic Area and other stakeholders such as Project managers, Manufacturing Plants, affiliates, R&D, Technical center & Product Developers.
ExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Under the general direction of the Provost and Vice President for Academic Affairs, the Associate Vice President (AVP) for Grants, Research, and Sponsored Programs (GRaSP) primarily focuses on collaboratively developing and implementing a strategic agenda to secure and manage extramural funding and elevating the profile of grant writing and scholarly activity.
$14,167 - $29,425 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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Position Overview: Aerovate is seeking a detail-oriented and strategic professional to fill the role of Senior Manager/Associate Director, Publications & Scientific Communications. Cross-functional Collaboration: Collaborate with cross-functional teams, including clinical development, regulatory affairs, market access, and commercial teams, to align medical affairs activities with clinical trial objectives, regulatory submissions, market access strategies, and commercialization plans.
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Real Estate: Advise clients on their federal, local and overseas tax affairs, while acting as a strategic consultant related to: deals and transactions (including mergers, acquisitions and investments, conversions, reorganizations, dispositions, joint ventures, fund formation and structuring, etc.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Provide leadership for the MSL function by participating on cross functional teams leading to strategic planning and working collaboratively with Commercial Operations including, Sales, Marketing and Medical & Scientific Affairs.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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The Associate Director of Regulatory Affairs (RA) Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with Labeling Management Team (LMT) and Executive Labeling Committee (ELC) as appropriate, and participating in label-related Health Authority negotiations.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvote
Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination Products And Devices
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The Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination Products and Devices, combines the knowledge of scientific, regulatory, and business issues to support labeling for products that are developed, manufactured or distributed to meet required legislation.
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Provide AZ technical functions with clear, concise guidance on current CMC regulatory requirements to support business tactical strategic planning. Direct Regulatory Affairs CMC experience, ideally in a development environment.
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Reporting to the SVP of Global Human Resources, the VP HR, R&D and Regulatory/Clinical Affairs will be accountable for end-to-end HR leadership for the R&D organization globally and serve as the primary strategic business partner to the SVP, R&D and the SVP, Regulatory and Clinical Affairs.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Ability to remain current on CMC regulatory intelligence, including guidelines and regulatory trends, and to drive and implement strategic policy decisions. Minimum of 8 years of pharmaceutical/biotech experience, including 5 years of Global Regulatory Affairs (CMC) experience.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Minimum 8 years of relevant experience in CMC Regulatory Affairs. Work experience in Regulatory Affairs or related discipline. Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions (such as Drug Product Development, Drug Substance Development, Analytical/QC, and Quality teams.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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The role of Associate General Counsel, Global Therapeutics – Specialty & Medical Affairs is responsible for developing legal strategy and driving strategic initiatives in support of AbbVie medicines in the Specialty franchise (e.g., Women’s Health, Endocrinology, Gastrointestinal Disorders, Hepatitis C) as well as legal support for AbbVie’s Medical Affairs organization.
Full-timeExpandApply NowActive JobUpdated 17 days ago
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