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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.
$250Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
$160,000 - $200,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
$221,170 - $286,220 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Student Affairs, academic or work experience related to the fields of social work, community organizing, arts & media organization, student affairs, counseling psychology, race & ethnic studies.
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Requires Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Industrial Engineering Management, Regulatory Affairs, Regulatory Science, or related field and 7 years of progressive post-baccalaureate experience as a quality engineer, validation engineer or any quality assurance occupation in medical device or regulated industry.
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Collaborate with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Requires Masters degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and six years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs, or a Bachelors degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and eight years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs.
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Familiar with regulatory standards and quality systems (e.g., GLP, GMP). Associate Director, Analytical Development, Raw Materials. Extensive hands-on experience in a wide range of analytical techniques, such as UV-Vis, HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
$150Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This exciting and influential role will serve as Synopsys’ strategist and engagement lead for State and Local Government Affairs, including legislative, regulatory and policy objectives and ensure the integration and execution of these objectives to support the State and Local and broader Government Affairs strategy.
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8-10+ years in pharma or biotech industry (Gene or Cell Therapy), including at least 5 years leading a Medical Affairs organization (Ophthalmology experience preferred) The Director/Senior Medical Affairs will be responsible for the alignment of internal stakeholders (Therapeutic Heads/MSLs) on a holistic engagement strategy plus executing the development of relationships within the Medical Expert community.
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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.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Department of Genetics is seeking an experimental or hybrid experimental/computational research associate in genomics (Life Science Research Professional 1) to join the Engreitz Laboratory to map the regulatory wiring of the human genome to discover genetic mechanisms of heart diseases.
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Collaborate with cross functional teams (drug substance, drug product, supply chain, quality, CMC regulatory, CMC PM, Clinical, DMPK and tox, as well as program management) to ensure CMC and program goals are met.
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Prior experience in healthcare and/or digital health marketing with awareness of the regulatory issues and understanding of promotional regulatory requirements. At least 3 years prior experience in search engine optimization (SEO), search engine marketing (SEM), content marketing, email marketing, digital advertising, and social media marketing.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Menlo Park, CA
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