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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Track animal care and sustainability developments in legislative/regulatory affairs across species (cage-free, animal medication/housing, etc.) Work alongside Coca-Cola corporate teams to identify issues, legislative, regulatory, and lobbying opportunities.
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Reporting to the Chief Compliance Officer, the Assistant General Counsel - Regulatory Affairs provides legal support to each of ITW’s Segments and Corporate functions as needed on a variety of regulatory matters, with a principal focus on monitoring and advising ITW businesses regarding existing and developing legal and regulatory issues affecting the company’s operations and products.
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As time allows, the Manager for Regulatory and Legislative Affairs will also assist in representing the Trust's interests at the Maine Legislature and other policy and regulatory forums.
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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs and small molecules.
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Our work depends on Regulatory Affairs Manager joining our team to contribute to PKI and Identity Management policy development, technical liaison and advisor. Seize your opportunity to make a personal impact as a Regulatory Affairs Manager supporting a PKI Government High Value Asset Mission Essential Function program.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions Regularly informs regulatory leadership of important timely issues.
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The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vice Presidents to develop regulatory strategies to ensure registrations are obtained and maintained to meet business objectives and timelines.
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We invested in new offices, sector teams and practice groups including higher education; foundations; 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.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Years’ experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. Maintain up-to-date knowledge of current and future product stewardship, chemical regulatory compliance, and sustainability issues through membership in trade associations and external committees, regular review of relevant publications and subscription services, and interactions with external experts and advisors.
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regulatory affairs jobs Company: Addus Homecare in Raleigh, West Virginia
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