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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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High School Diploma/GED from AND ten (10) years of (combined product stewardship, regulatory affairs, or EHS experience in a private, public, government or military environment. Bachelor’s Degree or higher AND three (3) years of combined product stewardship, regulatory affairs, or EHS experience in a private, public, government or military environment.
$145,537 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents. Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.
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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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Supporting the Head of U.S. Government and Regulatory Affairs and Head of the DC Office to develop and execute a Washington, DC public policy strategy with the U.S. Congress, U.S. Administration, and U.S. regulatory agencies.
$175,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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This individual will work collaboratively with members of all departments within the company, including but not limited to Offshore Wind Development, Onshore Development, Origination, Transmission, Regulatory, and Environmental Compliance & Strategy.
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KNOWLEDGE, SKILLS, and ABILITIES Bachelors in any of the following degrees from an accredited university/college: Regulatory Science, Regulatory Compliance, Regulatory Affairs, Environmental Science, biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and engineering.
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OPPORTUNITY Mammoth is hiring aDirector/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
$260,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure. Partners with Sr. Privacy Counsel, Cyber Security, IT, Regulatory Affairs and Enterprise Risk Management to help manage privacy risk exposure.
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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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Other duties as assigned by the Dean of Enrollment Management & Student Affairs. The Director of Career Pathways Advising will serve as a part of the Student Affairs leadership team and promote the active integration of the College's Career Pathways Advising model and related completion strategies within Student Affairs and throughout the college.
$62,283.23 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs, clinical and medical affairs, quality management, project management, finance, business operations, research and development, biometrics, health economics and outcomes research or manufacturing.
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Work closely with the Head of Scientific Affairs & Strategic Partnerships and Scientific Affairs team to produce rapid, thoughtful responses to content-related requests from across Pfizer Oncology (CSO, Medical strategy, BoD, Investor Relations, colleagues, etc.
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regulatory affairs jobs Company: Onestaff Medical in Cody, Wyoming
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