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Develop strong and close working relationships with key Gilead markets (G9) and cross-functional partners (Medical Affairs, Global Decision Sciences and Insights, Public Affairs, Government Affairs, Value and Access, Clinical Development, Competitive Intelligence, Legal, and Regulatory Affairs.
$355,410 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the VP Clinical/Medical Affairs and Head of Medical Office, the Senior Director of Medical & Patient Affairs (MPA) will be a senior member of the MPA team and a key member of the Medical Office.
$275,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Allogene is seeking a Director of Regulatory Affairs within the Regulatory Strategy group who will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products.
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Experience leading cross-functional integrated strategies and partnering with Governmental Affairs, Public Affairs, Medical Affairs, R&D, V&A, GDSI, Legal and Regulatory partners.
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The Executive Director is also responsible for the leadership of the International Education Division of the District Office and coordination of the College International Student Program Offices to support a robust international education program in the SMCCCD. The Executive Director will provide leadership for the strategic planning, development, and implementation of international affairs and global strategies, as well as promote and support international programs, students, and initiatives.
$249,948 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Executive Director of Community and Government Relations reports to the Chancellor and will manage public affairs, government, media, and community relations, oversee employee housing, district committee coordination, county-wide strategic initiatives and partnerships, and other duties as assigned.
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This role reports to the Associate Director, Business Intelligence and will work closely with cross-functional teams, including Sales, Marketing, Market Access, Medical Affairs, Compliance, Global Technical Services (GTS), Business Planning, and GTS organizations.
$181,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Support strategic partnerships with our cross-functional stakeholders in Medical Affairs, Global Medical Strategy and Operations, Legal, Ethics &Compliance, and R&D Quality. Ensure appropriate documentation of all Medical Affairs HCP engagement and other relevant activities in partnership with relevant stakeholders.
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. The Director/Sr will be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of Adverum’s development program/s.
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The optimal candidate participate will lead the department and also collaboratively work across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system.
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Title: Vice President of Quality Assurance & Regulatory Affairs. Experience with FDA and EU MDR regulatory processes. Additionally, in this role you will coordinate and work with a number of outside regulatory consultants to implement Neptune’s regulatory strategy across its diverse product lines.
$325,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
$170,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Head of Legal Affairs will report to the CEO and play a key role in overseeing a broad range of legal and business matters. 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.
$340,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Recruit and manage an appropriate mix of internal staff and consultants to supply appropriate expertise and bandwidth to execute the regulatory strategy. Develop, implement, and maintain the company’s quality assurance and regulatory strategy to ensure product safety and efficacy and support business objectives.
$325,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
affairs job Title: sr regulatory affairs in San Mateo, CA
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