- 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 ... 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 (Exton, PA)
- … regulatory submissions, including BLA preparation, and a history of successful FDA or international regulatory agency inspections are also essential. The ... implementation, collaboration with clinical operations and quality assurance for regulatory compliance, and leading manufacturing scale-up for flagship products. The… more
- Unknown (Fort Worth, TX)
- …ability to manage multiple projects and work effectively under pressure. Experience in FDA regulatory and quality assurance matters is preferred. The role ... requires a professional who is adept at problem-solving, and decision-making, and who can lead continuous improvement initiatives within the legal department. Hiring Manager Title Executive Director, Associate General Counsel Travel Percent Less than 10%… more
- Unknown (Oklahoma City, OK)
- …process optimization, and GMP compliance is essential, as is familiarity with US FDA and EU regulatory requirements. The role requires excellent problem-solving ... technology transfer, scale-up, and supporting audits and inspections to ensure GMP and regulatory compliance. Applicants for the Head of MST position at the company… more
- Unknown (Columbus, OH)
- …litigation background. Deep experience in a highly regulated field, particularly with FDA and healthcare regulatory frameworks, is strongly preferred. The role ... and a business-oriented mindset. Responsibilities include leading litigation and regulatory strategy, managing risk, and building scalable, tech-forward legal… more
- Unknown (Las Vegas, NV)
- …industry, with at least 5 years in a leadership role. In-depth knowledge of regulatory requirements and guidelines, including FDA , EMA, and ICH regulations, is ... Vice President, Regulatory Compliance About the Company Respected organization in...Role The Company is seeking a Vice President of Regulatory Compliance to join their team. The successful candidate… more
- Unknown (Boston, MA)
- …The ideal candidate will have a proven track record of successful interactions with regulatory agencies, a solid knowledge of FDA , EMA, and ICH guidelines, and ... Vice President of Regulatory Sciences About the Company Innovative biotechnology (BioTech)...Role The Company is seeking a Vice President of Regulatory Sciences to join their dynamic team. The successful… more
- Unknown (Fort Worth, TX)
- Vice President, Regulatory Affairs, Oncology About the Company Globally-recognized pharmaceutical company Industry Pharmaceuticals Type Privately Held Founded 2023 ... Role The Company is seeking a Vice President for Regulatory Affairs in Oncology. The successful candidate will be...teams, and ensuring the compliance of promotional materials with FDA regulations and company policies. Applicants for the Vice… more
- Unknown (Lebanon, PA)
- …and regulatory approval efforts, including the creation and submission of various regulatory documents to authorities such as the FDA and Health Canada. This ... Vice President of Regulatory and Clinical Affairs About the Company Pioneering...Company is in search of a Vice President of Regulatory and Clinical Affairs to play a pivotal role… more
- Unknown (San Francisco, CA)
- …assets from early-phase trials through regulatory approval. Extensive experience in regulatory interactions with FDA and EMA, as well as global trial ... of a Head of Clinical Development (S/VP) to spearhead the clinical and regulatory strategy for its pioneering pipeline of antibody drug conjugates in cancer… more
- Koch Foods (Fairfield, OH)
- …advertising/promotional claims through the development and maintenance of label, nutrition, and regulatory files per standards. Act as subject matter expert to apply ... FDA /USDA regulations and its standards and principles of food...with the department manager and other appropriate resources. Provide regulatory perspective for new and legacy products, and help… more
- 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 ... alignment with regulatory and commercial objectives. This role also involves building...of hands-on leadership in late-stage clinical programs leading to FDA approval. Deep experience in injectable aesthetics, neurotoxins, or… more
- Unknown (San Diego, CA)
- …objectives. The VP will be responsible for the scientific direction of global regulatory toxicology, safety assessments, and will oversee a team of in-house and ... requires a proven track record in interfacing with global regulatory authorities, designing, and interpreting safety studies for ...The ideal candidate will have a deep knowledge of FDA and EMA requirements for nonclinical safety submissions, and… 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 ... or biotechnology industry, and a proven track record in regulatory submissions. The Senior Director will also be expected...stay current with the latest developments in biostatistics and regulatory guidance, and to have a strong knowledge of… more
- SOFIE (Miami Lakes, FL)
- …cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations. Ensure compliance with radiation and laboratory safety ... from groups of managers, clients, customers, the public required, or regulatory agencies required. Ability to define problems, collect data, establish facts,… more
- Unknown (San Diego, CA)
- …interactions with clinical stakeholders. The role also involves input into regulatory strategy, management of clinical studies, and ensuring adherence to good ... with both internal and external stakeholders. A strong background in relevant FDA regulations, particularly in rare disease drug development, and experience in… more
- Unknown (Somerville, MA)
- …leadership, and a proven track record in late-stage clinical development and regulatory readiness. The role demands a leader with exceptional communication skills, ... improvement. The VP, Head of Quality will be expected to interface with regulatory authorities, build and develop a high-performing Quality team, and champion total… more
- Unknown (Redwood City, CA)
- …of clinical study results, and will serve as a primary interface with regulatory authorities, key opinion leaders, and external experts. This role requires a ... developing talent within their teams, ensuring adherence to GCP, ICH, and FDA /EMA guidelines, and driving the clinical vision to integrate translational science, … 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… more
- Unknown (Austin, TX)
- …within aggressive timelines, on budget, and in full compliance with all relevant regulatory guidelines. This role involves leading a team of internal and external ... 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… more
