- Unknown (Raleigh, NC)
- …global clinical trials, serving as the primary medical interface with the FDA , and defining clinical endpoints, safety strategy, and benefit-risk positioning in ... record of hands-on leadership in late-stage clinical programs leading to FDA approval. Deep experience in injectable aesthetics, neurotoxins, or closely related… more
- Keurig Dr Pepper (Columbus, OH)
- …Occupational Safety & Health Administration (OSHA) and Food and Drug Administration ( FDA ). Ensure all equipment, including but not limited to forklifts, pallet ... jacks, and fleet trucks, is properly maintained and inspection practices are followed. Total Rewards: $55,700 - $78,000 / year Actual placement within the compensation range may vary depending on experience, skills, and other factors Benefits, subject to… more
- Keurig Dr Pepper (Columbus, OH)
- …by Occupational Safety & Health Administration (OSHA) and Food and Drug Administration ( FDA ). * Ensure all equipment, including but not limited to forklifts, pallet ... jacks, and fleet trucks, is properly maintained and inspection practices are followed. Total Rewards: * $55,700 - $78,000 / year * Actual placement within the compensation range may vary depending on experience, skills, and other factors * Benefits, subject to… more
- Unknown (Oklahoma City, OK)
- …optimization, and GMP compliance is essential, as is familiarity with US FDA and EU regulatory requirements. The role requires excellent problem-solving skills, ... strong communication, and a spirit of teamwork. The ideal candidate will also demonstrate strong leadership and talent development capabilities, with a focus on continuous improvement for the MST team. Proficient English language skills are a must. Travel… more
- Unknown (Columbus, OH)
- …background. Deep experience in a highly regulated field, particularly with FDA and healthcare regulatory frameworks, is strongly preferred. The role demands ... a proven track record in managing and developing legal teams, as well as experience in strategic business advisory and commercial, labor, and transactional legal matters. The ideal candidate will be a transformational leader, capable of making pragmatic,… more
- Unknown (San Diego, CA)
- …with both internal and external stakeholders. A strong background in relevant FDA regulations, particularly in rare disease drug development, and experience in ... interactions with regulatory agencies is essential. The role requires a results-oriented work ethic, a positive attitude, and the highest ethical standards. Experience in translational medicine, clinical pharmacology, and early-stage development is a plus, as… more
- Unknown (Columbus, OH)
- …in oligonucleotide synthesis, and purification, and a deep understanding of cGMP, FDA , and EMA guidelines are essential. The role also involves authoring and ... reviewing regulatory filings, leading tech transfer activities, and managing a team to meet the demands of the advancing pipeline. Applicants for this role at the company should hold a minimum of a Bachelor's degree in a relevant field, with a Master's or PhD… more
- Unknown (Austin, TX)
- …diseases, is preferred. The ideal candidate will have an excellent understanding of FDA guidelines, GCP, ICH, and applicable SOPs, and a proven track record in ... recruiting, managing, and training operations team members. The role requires the ability to manage CROs to meet or exceed KPIs, lead a clinical operations team, and collaborate with internal colleagues to achieve program goals. Strong communication skills and… more
- Unknown (San Jose, CA)
- …include overseeing the statistical aspects of regulatory submissions, particularly with the FDA , and ensuring the quality and integrity of data analysis and ... reporting. The role demands a Ph.D. in biostatistics, statistics, or a related field, a minimum of 12 years of experience in the pharmaceutical or biotechnology industry, and a proven track record in regulatory submissions. The Senior Director will also be… more
- Unknown (Watertown, MA)
- …supporting real-time decision-making through data analysis, and contributing significantly to FDA submissions and meetings. Applicants for this role at the company ... should hold a Ph.D. in biostatistics, statistics, mathematics, or a related field, with a minimum of 8-10 years' experience in biostatistics for clinical and diagnostic development, including a strong background in companion diagnostics. The position requires… more
- Unknown (Grand Junction, CO)
- …and optimizing supply chain, manufacturing, logistics, and fulfillment, particularly in an FDA certified and GMP facility. The role is both strategic and hands-on, ... requiring the creation of robust processes, systems, and people strategies to support significant revenue and profit growth. The COO/VP Operations will also oversee finance, HR, technology, and compliance, and will be a key partner to the CEO in executing the… more
- Unknown (Cranbury, NJ)
- …Approval designations, as well as a significant level of interaction with the FDA , EMA, and other regulatory agencies, is highly valued. Hiring Manager Title Chief ... Medical Officer Travel Percent Less than 10% Functions Operations more
- Unknown (Somerville, MA)
- …well-suited for this position. The candidate should have a deep understanding of FDA and EMA regulations, experience with cGMP requirements, and a successful track ... record in contributing to IND, BLA, and MAA submissions for novel products. Hiring Manager Title Chief Legal Officer Travel Percent Less than 10% Functions Operations more
- Unknown (San Diego, CA)
- …regulatory submissions. The ideal candidate will have a deep knowledge of FDA and EMA requirements for nonclinical safety submissions, and a collaborative mindset ... capable of excelling within multi-discipline discovery and development teams. Key responsibilities include providing strategic and operational leadership for the toxicology group, advising on the impact of toxicology findings on program goals, and actively… more
- Unknown (Raleigh, NC)
- …in supporting the financial aspects of capital device implementation and FDA remediation efforts. The successful candidate will be responsible for maintaining ... and evolving cost-per-device models, leading revenue recognition, and partnering with various cross-functional teams to drive process improvement and efficiency. Clear communication skills and the ability to present financial insights and recommendations to… more
- Unknown (Boston, MA)
- …drug safety within the biotechnology or pharmaceutical industry. In-depth knowledge of FDA safety regulations, ICH Guidelines, EU GVP, and other global safety ... regulations is essential, as is expert knowledge of safety database applications and signal detection. The role requires strong leadership skills, the ability to mentor teams, and excellent communication skills to influence senior leadership and external… more
- Unknown (Phoenix, AZ)
- …well as leading special projects and initiatives. While not mandatory, knowledge of FDA , FTC, healthcare/medical device laws, and data privacy regulations is a plus. ... The candidate should be self-motivated, capable of working with minimal direction, and have a good sense of humor with a genuine interest in relationship building. Experience with key software platforms such as Microsoft Office, Google Workspace, and others is… more
- Unknown (Exton, PA)
- …regulatory submissions, including BLA preparation, and a history of successful FDA or international regulatory agency inspections are also essential. The role ... demands a leader who can build and lead a world-class manufacturing and facilities organization, champion a culture of regulatory compliance, and proactively identify and resolve operational challenges. Travel Percent Less than 10% Functions Operations more
- Unknown (Conshohocken, PA)
- …will have a deep understanding of the US healthcare landscape, including FDA regulations, and experience in the successful management of medical affairs activities. ... The Executive Director should embody the company's values of leading with science, being entrepreneurial, and demonstrating the highest levels of ethics and integrity. Hiring Manager Title Head of Medical Affairs Travel Percent 30% Functions CEO/President… more
- Unknown (Las Vegas, NV)
- …a leadership role. In-depth knowledge of regulatory requirements and guidelines, including FDA , EMA, and ICH regulations, is essential. The role requires strong ... leadership, analytical, and problem-solving skills, as well as a high level of attention to detail and accuracy in regulatory documentation. The ideal candidate will have excellent project management skills, the ability to adapt to changing regulatory… more
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