- Unknown (Fort Worth, TX)
- …commercial product regulatory affairs. The VP will be accountable for regulatory submissions , communications, and compliance across the company's new and ... strategies. This includes the management of IND and NDA submissions , global regulatory interactions, and international submissions . The role also involves… more
- Unknown (Gaithersburg, MD)
- …in scientific regulatory strategy, and a strong background in managing regulatory submissions globally. Candidates for the Vice President of Regulatory ... a team in the development and execution of scientific and tactical regulatory strategies, submissions , approvals, and compliance throughout the drug development… more
- Unknown (Alameda, CA)
- …industry practices, and experience in the preparation of complex documents for regulatory submissions , particularly IND, NDA/BLA/MAA. Certification in a relevant ... Vice President, Regulatory Science Communications About the Company Accomplished biopharmaceutical...preferred, as is in-depth experience with electronic systems for submissions . The role demands a strategic and proactive approach,… more
- Unknown (San Francisco, CA)
- …input to non-clinical and clinical development programs, leading the preparation of various regulatory submissions , and serving as the primary point of contact ... Head of Regulatory Affairs About the Company Top biotechnology (BioTech)...the Role The Company is seeking a Head of Regulatory Affairs to provide strategic leadership and oversight of… more
- Unknown (Cranbury, NJ)
- …with a focus on gene therapy and a proven track record of successful regulatory submissions , including accelerated approvals. They should be adept at managing a ... Senior Vice President, Regulatory Affairs About the Company Innovative clinical-stage biotechnology...The Company is seeking a Senior Vice President for Regulatory Affairs to join their dynamic team. The successful… more
- Unknown (San Diego, CA)
- …with global regulatory authorities, designing, and interpreting safety studies for regulatory submissions . The ideal candidate will have a deep knowledge of ... will be responsible for the scientific direction of global regulatory toxicology, safety assessments, and will oversee a team...FDA and EMA requirements for nonclinical safety submissions , and a collaborative mindset capable of excelling within… more
- Unknown (San Jose, CA)
- …disorders. Responsibilities for this role include overseeing the statistical aspects of regulatory submissions , particularly with the FDA, and ensuring the ... the pharmaceutical or biotechnology industry, and a proven track record in regulatory submissions . The Senior Director will also be expected to stay current with… more
- Unknown (Charlotte, NC)
- …clinical trials, as well as the preparation of key clinical documents for regulatory submissions . Collaboration with internal and external partners is essential, ... submissions , and a history of successful interactions with regulatory authorities. Strong leadership, communication, and strategic planning skills are essential,… more
- Unknown (Exton, PA)
- …technology transfer and scale-up of cell culture systems. Experience with complex regulatory submissions , including BLA preparation, and a history of successful ... implementation, collaboration with clinical operations and quality assurance for regulatory compliance, and leading manufacturing scale-up for flagship products. The… more
- Unknown (Warren, NJ)
- …statutory filings, coordinating Audit Committee reporting, and managing various other regulatory submissions . The role also involves leading accounting research, ... in overseeing the planning, preparation, and coordination of statutory and regulatory financial filings. The successful candidate will be responsible for ensuring… more
- Unknown (Los Angeles, CA)
- …peer-reviewed journals. Preferred experience includes involvement in registration-enabling strategies, regulatory submissions , and the ability to represent ... development strategy and its execution to ensure alignment with scientific, regulatory , and business objectives, overseeing clinical trial design, conduct, and data… more
- Unknown (St. Paul, MN)
- …the timely and budgeted completion of product design, transfer to manufacturing, and regulatory submissions . The role requires a candidate with a strong ... both orally and in writing. Collaboration with marketing, sales, quality, and regulatory teams is essential to understand and shape product needs and ensure… more
- Unknown (Bothell, WA)
- …worldwide. The VP will also be involved in safety analysis for regulatory submissions , collaborating with cross-functional teams, and providing expert guidance ... for developing and implementing the pharmacovigilance strategy in line with regulatory requirements and company goals. This role involves building and leading… more
- Unknown (Columbus, OH)
- …immune-mediated diseases or related therapeutic areas, as well as successful regulatory submissions and interactions. Strong leadership, team management, ... the design and execution of clinical trials, and ensuring compliance with regulatory requirements. This role involves overseeing the preparation and submission of… more
- Unknown (Waltham, MA)
- …standard operating procedures related to drug safety and will support global regulatory submissions for new products, formulations, or indications. Travel ... of products throughout their lifecycle, in compliance with global regulatory requirements and organizational objectives. Key responsibilities include leading the… more
- Unknown (Newark, NJ)
- …providing medical and scientific input to core project documents, overseeing regulatory submissions , and disseminating clinical data through various channels. ... ensuring they meet the highest standards of ethics, scientific merit, and regulatory compliance. The successful candidate will be responsible for the design,… more
- Unknown (Philadelphia, PA)
- …stakeholders. The VP will be instrumental in driving the preparation of regulatory submissions , study reports, and scientific publications. Applicants for the ... and safety reviews. The role also involves cross-functional collaboration with regulatory , pharmacovigilance, biometrics, and clinical operations teams, as well as… more
- Unknown (Cambridge, MA)
- …with establishing and overseeing technical standards, driving CMC planning for global regulatory submissions , and leading a high-performing CMC development team. ... formulation science, analytical development, and a strong working knowledge of regulatory requirements are essential. The role also demands a proven ability… more
- Unknown (San Francisco, CA)
- …will be responsible for driving innovations, particularly in the context of regulatory submissions , and will be instrumental in setting strategic directions ... highly valued. The ideal candidate will have a deep understanding of regulatory guidelines, medical and biological terminology, and clinical practice in the relevant… more
- Unknown (Indianapolis, IN)
- …of accounting activities, including the month-end close, financial reporting, and regulatory submissions . This role involves close collaboration with the ... CFO, contributing to board reporting, and ensuring compliance with all relevant financial regulations. The VP Controller will also be tasked with maintaining strong internal controls, identifying opportunities for efficiency and automation, and mentoring a… more
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