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External Affairs consists of Communications, Government and Regulatory Affairs, Labor and Workforce Planning, and Community Engagement teams. External Affairs leads Vineyard Offshore’s external presence at the local and state level.
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Join Arkema in Wauwatosa, USA, as a Product Stewardship and Regulatory Affairs Specialist. If you are a driven individual with an interest in regulatory affairs and product stewardship, apply now.
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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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On-Board Scientific is hiring a Nonclinical Regulatory Document and Scientific Writer based out of either New Brunswick, Lawrenceville or Summit, NJ! Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
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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.
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Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
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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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Minimum of 4 years combined regulatory affairs, compliance, product development, nutrition or technical related experience required, with strong knowledge of FDA and USDA food regulations.
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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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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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The Global Public Policy team’s work spans a broad and diverse range of functions and workstreams, including government affairs and government relations; policy, product, and issue area expertise; risk and crisis management and mitigation; outreach, coalitions, and partnerships; and philanthropy.
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Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.
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The Counsel position will be an integral part of the Regulatory, Operations, Government Affairs and Environmental team. The Counsel will assist the Deputy Chief Counsel and Principal Counsel on various transactional, operational and regulatory legal matters primarily for Disney Signature Experiences (with a focus on Disney Cruise Line) and also the Walt Disney World Resort.
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Manage third party consultants to fulfill regulatory filing obligations, both initial and ongoing – including but not limited to EIA, FERC/NERC, DOE, PUCs, ERCOT, CAISO, MISO, ISO-NE, PJM, environmental attribute compliance entities, and any state or local regulatory requirements.
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
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regulatory affairs jobs Company: Spencer Britt in Moapa, Nevada
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