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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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2) Business Relationship Management: • Foster close relationships with the Care Chemicals business and technology personnel, Quality Managers, as well as Global Product Stewardship & Regulatory Affairs colleagues, Trade Associations, and/or NGOs. • Develop and document business-specific PSRA objectives and strategies aligned with the overall business strategy.
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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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As a Regulatory Affairs Specialist, you'll play a pivotal role in upholding our mission by ensuring regulatory compliance and promoting the well-being of pets worldwide. As a Regulatory Affairs Specialist, you'll be an integral part of our mission-driven team, working collaboratively to ensure that our products meet the highest standards of safety, quality, and regulatory compliance.
$95,000 - $113,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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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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Assist the Regulatory Affairs Specialist in preparing, submitting, and processing approvals from the IRB and other Penn review entities for new research studies as well as for continuing reviews, modifications, reportable events, and study closures throughout the life of a study.
$43,919 - $52,661 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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 issuesStays abreast of regulatory procedures and changes in regulatory climate.
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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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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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Counsel and advise the BU in areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of the BU(s) products.
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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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Minimum seven (7) years customs brokerage, customs consulting, regulatory or similar professional services is required. Actively manage and continuously develop a team of compliance professionals providing day to day support of regulatory and compliance-based inquiries.
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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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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
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POSITION SUMMARY Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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regulatory affairs jobs Company: Simventions Inc Glassdoor in Suwanee, Georgia
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