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The current role is for a Senior Director, Regulatory Affairs to join our team and advance our platform. Minimum 8 years of relevant regulatory leadership experience in the biotech and pharmaceutical industry; gene editing/gene therapy drug development program experience is a requirement.
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Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience. Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.
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Advanced knowledge of the international/sustainable development, public policy, and public affairs and international development job markets spanning the public, non-profit and private sector (in the US and internationally.
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Our teams include Communications, Community Impact and Investment, Community Finance, CRA Strategy and Program Management, the Government and Political Affairs Group, Regulatory Relations, and Strategy and Engagement.
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Ability to communicate and collaborate with other functional areas including drug discovery, nonclinical toxicology, CMC, clinical development, quality assurance and regulatory affairs. Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biotherapeutics; experience having direct interaction with FDA and other regulatory agencies, including submission of IND, NDA and other regulatory documents is required.
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Reporting directly to the head of medical affairs, the Senior Director will play a pivotal role in leading the development and execution of strategies to generate and leverage real-world evidence to support the launch, development, market access, and commercialization of Aerovate's novel cardiopulmonary therapy.
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As the Director of Regulatory Compliance (MLRO), you will be working as part of Nium's global, dynamic Compliance team and will be reporting to the VP Compliance (US). Perform ongoing AML and OFAC risk assessments and horizon scanning for applicable regulatory requirements.
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The Medical Science Liaison (MSL) is a member of a field-based team who function as an extension of the US Medical Affairs organization. MSLs provide medical information through scientific exchange in a fair- balanced manner and provide clinical/scientific support for Bristol Myers Squibb and the Medical Affairs department at the direction of Medical Affairs management.
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Our Regulatory Affairs team is seeking a highly motivated Regulatory Operations Manager. Reporting to the Senior Director of Regulatory Operations, you will be responsible for assembling, formatting, and publishing regulatory dossiers (e.g., IND, CTA, BLA, MAA) for global registration and lifecycle management submissions (e.g., supplements, amendments, variations) to meet corporate objectives for both ongoing business and new product development.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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Strong knowledge of pharmacokinetics and modeling, pharmacodynamic principles, ADME concepts, bioanalytical principles, regulatory guidelines and clinical pharmacology requirements in late stage clinical development.
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Lead and develop a team of regulatory affairs professionals in areas such as HazCom management, product stewardship, new product development support, labeling reviews, and lifecycle support activities.
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People: We have transitioned thousands of officers into successful careers in law enforcement, government services, foreign affairs and many more. About Inter-Con Security Passion: Joining the Inter-Con family is an opportunity for growth in an environment that truly cares for its employees.
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Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing. Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements.
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Serve as the main administrative coordinator for the Office of Student Affairs events and work independently to oversee event logistics (including event planning, social media, event promotion, room set-up/clean-up, catering, AV, and IT) and coordinate with departments and offices on main campus and at the law school as needed.
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regulatory affairs jobs Title: sr Company: Csl Behring in Oakland, CA
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