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Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative team across our Research/Pre-Clinical, CMC, Regulatory, Clinical, and Quality organizations to author and drive development of key documents in support of all of our Phase 1 through Phase 3 programs.
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Provide expert CQA guidance and strategic coaching to stakeholders (e.g. Clinical Research, Clinical Operations, Data Management, Pharmacovigilance) to support regulatory inspections. Experience in managing or supporting clinical trial or Drug Safety-related regulatory inspections a plus.
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Please review the minimum qualifications for the Public Utilities Regulatory Analyst III position here. The CEQA and FERC Branch plays an important role in permitting transmission and substation facilities throughout the state and is responsible for the development of environmental documents in accordance with CEQA and overseeing projects in construction.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such as clinical research coordinator experience. Assist PI with the development of concept sheets, investigational brochure or package insert for CRSO regulatory protocol editor for investigator-initiated trials.
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Our health care/FDA jobs focus on the following areas: regulatory compliance, product development and approval strategies, recalls, promotion and advertising compliance and enforcement, due diligence and transactional support involving FDA regulatory issues, administrative advocacy and litigation before agencies and the courts, competitive regulatory strategies, enforcement, and white-collar defense.
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Expertise/Advanced knowledge of biotechnology products, market dynamics, and regulatory requirements with strong disease knowledge in rare diseases, neurology, ophthalmology, and/or immunology drug development.
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Responsible for interacting directly with the sponsor and regulatory agencies such as HUD, CHFA, HCD, and TCAC.Attends meetings requested by regulatory agenciesResponsible for placing appropriate property insurance, as approved by the ownerDevelop and implement a marketing plan in accordance with existing Affirmative Fair Marketing Plan, as approved by JSCo. Marketing/ VacancyConducts regular inspections of property and vacant apartments.
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UC Berkeley Extension, the professional and continuing education division at the University of California, Berkeley, invites applications for a pool of qualified instructors to teach in-person and online Clinical Research, Regulatory Affairs, and Biotechnology courses for the Sciences, Mathematics and Biotechnology department.
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Reporting to the Telecommunications Project Manager, this position manages the site development process from site candidate qualification, design, leasing, zoning, regulatory approval, permitting and handoff to construction.
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You will assist in monitoring and analyzing federal, state, and local regulatory developments concerning lending, servicing, and other activities that may impact our marketplace and engage with our business partners to ensure understanding of the same and operational readiness.
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We are seeking a Senior Medical Science Liaison (Senior MSL) - this is an opportunity to join Xenon in a field-facing role and to help shape the development of the MSL function and team within wider Medical Affairs and Clinical Development teams.
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We partner with our public policy, safety, security and privacy experts to define transportation policy for the autonomous driving world to come, advising on regulatory changes that support and protect our users around the world.
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Over 10 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. Lycia Therapeutics is seeking an innovative Head of Regulatory Affairs with a strong background in global regulatory strategy development to support the development of Lycia programs.
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Ideal candidates will also have some contentious practice experience, such as working on regulatory investigations and/or litigation, ideally focused on tech, data, privacy, cybersecurity or related issues, have experience with drafting and reviewing data processing agreements, privacy policies, and security policies, as well as providing day-to-day privacy advice to in-house counsel and start-up executives.
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The Environmental Scientist will work collaboratively with the Regulatory Division’s Sediment Management Program to coordinate regional efforts, involve key stakeholders, investigate, and develop new policies around sediment and soil issues and include a financing strategy to help tackle funding needs.
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regulatory affairs jobs Title: sr Company: Csl Behring in South San Francisco, CA
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