- 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 (Dallas, 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 (Phoenix, AZ)
- …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 (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
- Unknown (El Paso, TX)
- Vice President, Global Regulatory Affairs About the Company Respected biotechnology (BioTech) company Industry Biotechnology Type Privately Held About the Role The ... search of a Vice President/Senior Vice President for Global Regulatory Affairs. The successful candidate will be responsible for...in the biotech or pharma sector. Expertise in US FDA regulations and global health authority policies is essential,… more
- Unknown (Portland, OR)
- 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 (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 (Phoenix, AZ)
- …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 (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
- Christus Health (Sulphur Springs, TX)
- …Quality Control/ Quality Assurance in accordance with MQSA programs and ACR, FDA , and State standards and regulations. Assures that all documentation is accurately ... by State and Federal agencies, the hospital, and other regulatory entities. Coordinates/prioritizes imaging procedures throughout the workday, maintaining a… more
- Sanofi (Swiftwater, PA)
- …are distributed throughout the world. This position guarantees the Quality and Regulatory compliance of products developed, manufactured and distributed by the site ... in accordance with Regulatory requirements and Global Quality policies and standards. This...practical expertise with cGMP requirements including WHO, ICH, US FDA , Canadian BGTD, Australian TGA, EU GMP, Japanese ;… more
- Unknown (Woburn, MA)
- …degree in a relevant field, with a preference for a post-graduate degree in regulatory affairs or a commercial discipline. A minimum of 10 years of industry ... technology environments is mandatory, with a proven track record in obtaining FDA approvals and leading successful CE submissions. The Vice President, Quality… more
- Unknown (Woburn, MA)
- …of a Bachelor's degree in a relevant field, with a post-graduate degree in regulatory affairs or a commercial discipline being desirable. A minimum of 10 years of ... environments is mandatory, along with a proven track record in obtaining FDA approvals and leading successful CE submissions. The Vice President, Quality Assurance… more
- Unknown (Boston, MA)
- …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
- Unknown (Burlington, NC)
- …be responsible for ensuring that IT systems and processes meet global regulatory requirements and internal standards, while also promoting a culture of continuous ... role at the company should have a minimum of 10 years' experience in an FDA (GXP) regulated industry, with a Bachelor's degree in a relevant field. The ideal… more
- Unknown (Durham, NC)
- …for ensuring that IT systems and processes adhere to global regulatory requirements and internal standards. Key responsibilities include leading the development ... ensure compliance. Applicants must have a minimum of 10 years' experience in an FDA (GXP) regulated industry, with a Bachelor's degree in a relevant field. The ideal… more
- Unknown (Charlottesville, VA)
- …strong background in regulatory compliance, particularly in the areas of OHRP, FDA , and HIPAA. This role is pivotal in ensuring the highest standards of ethical ... Hiring Manager Title Associate Vice President for Research Compliance and Regulatory Affairs Travel Percent Less than 10% Functions CEO/President Non-Profit… more
- SOFIE (Somerset, KY)
- …Operations and Technical Services, you'll ensure all quality control systems meet strict FDA and cGMP standards (21 CFR 211 and 212). ESSENTIAL DUTIES AND ... the application of scientific principles and rationales and adherence to regulatory requirements. Collaborate with other production radiochemists and quality control… more
- JABIL CIRCUIT, INC (Hunt Valley, MD)
- …technology. Provide engineering and reliability support for all agency audits like FDA , MHRA, and EMA. Maintain all facility drawings of record, facility design ... cGMPs, Good Engineering Practice ('GEP'), Lean and Six-sigma, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like… more
- Unknown (Phoenix, AZ)
- …structuring, writing, and negotiating agreements, as well as advising on regulatory , compliance, privacy, and litigation matters. Applicants must have a Juris ... life sciences industry. Experience in healthcare regulation, including fraud and abuse, FDA for medical devices, data use and privacy, and anti-corruption, is highly… more
