- 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 (Fort Worth, TX)
- …ideal candidate will have a proven track record in preparing and submitting regulatory applications for drug or biologic products, with specific experience in ... Vice President, Regulatory Affairs, Oncology About the Company Globally-recognized pharmaceutical...teams, and ensuring the compliance of promotional materials with FDA regulations and company policies. Applicants for the Vice… more
- Unknown (San Francisco, CA)
- …clinical and regulatory strategy for its pioneering pipeline of antibody drug conjugates in cancer therapeutics. The successful candidate will be responsible for ... assets from early-phase trials through regulatory approval. Extensive experience in regulatory interactions with FDA and EMA, as well as global trial… 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 ... to lead a team of biostatisticians and provide strategic statistical input to drug development projects. The successful candidate will be at the forefront of… more
- Unknown (San Diego, CA)
- …strong background in relevant FDA regulations, particularly in rare disease drug development, and experience in interactions with regulatory agencies is ... interactions with clinical stakeholders. The role also involves input into regulatory strategy, management of clinical studies, and ensuring adherence to good… 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 (Somerville, MA)
- …will work closely with machine-learning and data scientists to revolutionize drug development, leveraging progressive tools, data, and innovative business processes. ... leadership, and a proven track record in late-stage clinical development and regulatory readiness. The role demands a leader with exceptional communication skills,… more
- Unknown (Watertown, MA)
- …Ambulance Medicine Manufacturing Chemical Products Oncology Specialties proteomics drug development multiplex tissue imaging biomarker discovery precision medicine ... aspects of exploratory and pivotal studies, ensuring robust methodology and regulatory compliance. The successful candidate will also be responsible for aligning… more
- Unknown (Boston, MA)
- …patient safety and the integration of safety into all aspects of the drug development process. The successful candidate will be responsible for leading and building ... safety and pharmacovigilance activities, and maintaining compliance with global regulatory standards. This includes establishing a safety and pharmacovigilance… 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 ... well as directly managing program-level responsibilities such as budget, timeline, and drug supply management. The Senior Director will also be tasked with leading… more
- Chiesi (Cary, NC)
- … affairs, FDA regulations, or drug development. + Familiarity with FDA regulatory pathways (eg, IND, NDA, BLA, orphan drug designation). + ... FDA information requests). + Conducting background research on FDA regulations, guidance, and regulatory precedents relevant...of fall 2026 or later. + Strong interest in regulatory affairs and drug development, particularly within… more
- Medtronic (Santa Rosa, CA)
- …dynamic and fast-paced environment. This position reports to the Senior Program Manager- FDA /Life Sciences, Enterprise Legal Regulatory . This will be an onsite ... **A Day in the Life** Medtronic is seeking an FDA /Life Sciences paralegal as a member of the Enterprise...Sciences paralegal as a member of the Enterprise Legal Regulatory (ELR) team with knowledge and experience navigating requirements… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, drug safety, market research, ... This position with the Regeneron Regulatory and Commercial Law team will provide proactive...to multiple internal stakeholders, including the commercial, medical affairs, regulatory , HEOR, corporate affairs, and compliance teams. Counsel will… more
- WuXi AppTec (Middletown, DE)
- … Compliance * Ensure all analytical testing meets FDA , EMA, and ICH regulatory requirements for drug product QC. * Maintain compliance with data integrity ... Strong understanding of ICH, USP, EP, JP, FDA , and EMA regulatory requirements for drug product QC. * Demonstrated ability to manage teams in a fast-paced… more
- WuXi AppTec (Middletown, DE)
- … Compliance * Ensure all analytical testing meets FDA , EMA, and ICH regulatory requirements for drug product QC. * Maintain compliance with data integrity ... USP <61>, <62>, <85>, <1116>, EP, JP, FDA , and EMA regulatory requirements for drug product QC. * Demonstrated ability to manage teams in a fast-paced… more
- Cardinal Health (Helena, MT)
- …Biotech and Medical Device/Medical Diagnostics with success + Experience selling consulting, drug development, regulatory services preferred + Highly organized + ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- CVS Health (Annapolis Junction, MD)
- …to address them + Communicate and educate staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, ... and compliance developments (eg, state Board of Pharmacy, DEA, FDA , etc.) for pending regulatory changes and...physician to receive hard copy of prescription and perform drug recall surveillance and reporting In this role, you… more
- Ascendis Pharma (Princeton, NJ)
- …combination products. + Experience managing major regulatory filing(s) to the FDA Office of Prescription Drug Promotion (eg, launch advisory comment ... guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Regulatory Affairs,...and/or disease education communications + Serve as the company's regulatory liaison to the FDA 's Advertising and… more
- Stanford Health Care (Palo Alto, CA)
- …Clinic Administration, Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug ... federal and state levels. + Knowledge of other relevant regulatory guidelines (eg, CMS, 340B, FDA ). +...other relevant regulatory guidelines (eg, CMS, 340B, FDA ). + Knowledge of theories, principles, practices and techniques… more
- Sumitomo Pharma (Montgomery, AL)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more
