- Jazz Pharmaceuticals (Redwood City, CA)
- … or quality issues resulting from executed partnerships. Partner with GRADS Compliance Regulatory and Labeling Partner to lead in the compliance analysis ... meeting and information, and ensuring timely responses. Collaborate with the GRADS Compliance Regulatory and Labeling Partner to ensure continuous improvement… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …opportunities for the GRA-CMC team and the broader GRA team. Ensure continued regulatory compliance of products though adherance to c hange control and Regul ... support. Lead the preparation and submission of responses to regulatory agencies are managed appropriately and in a timely fashion. Regularly interact… more
- Rocket Lab Corporation (Littleton, CO)
- …and assemble satellite hardware and software that supports other satellite missions. SENIOR RF REGULATORY LEAD ENGINEER I/II Join our team as the Senior RF ... Regulatory Lead Engineer I/II , where you'll...for Rocket Lab's cutting-edge systems and operations, ensuring full compliance with both local and international regulations. You'll have… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous ... living. Are you ready to make a difference? The Position The Patient Safety, Compliance & GxP Operational Excellence Lead is responsible for driving efficiency,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submission-related activities. Updates internal processes to ensure compliance with health requirements and expectations. Qualifications A Bachelor's ... lead the implementation of, process/system improvements related to regulatory submissions (Veeva Vaults RIM, Registrations, Publishing and AdPromoMats). May… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... gene therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical and project teams)Ability and… more
- Formation Bio (New York, NY)
- …pertaining to developing and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life ... treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the… more
- Insmed Incorporated (NJ)
- …meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all ... to ensure the company's RA CMC activities are aligned with regulatory expectations. Lead and mentor a team of CMC professionals, encouraging a collaborative… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development and delivery of training on case ... Evaluate training curricula and make adjustments based on feedback, compliance audits, and evolving regulatory standards Key Area #2 Lead the strategic… more
- Vaco by Highspring (Taunton, MA)
- …benefit programs, including 401(k) and deferred compensation, ensuring proper contributions and regulatory compliance . Lead efforts to streamline payroll ... integration. Strong knowledge of payroll laws, tax regulations, and compliance requirements. Effective leadership and team management skills. Strong analytical… more
- Merck & Co. (Millsboro, DE)
- …cycles and integrated fill-finish operations that affect product quality, throughput, and regulatory compliance .Act as the internal and external subject matter ... (freeze-drying) capacity being built at the site.This role is the Technical Lead for Lyophilization with both deep scientific experience and practical commercial… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …product profile (TPP) development, due diligence projects, and clinical- regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities Clinical ... OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects...etc.Provide expert recommendations based on scientific and medical analysis. Regulatory Compliance : Ensure adherence to FDA guidelines… more
- Merck & Co. (Millsboro, DE)
- …Product Manufacturing, Pharmaceutical Manufacturing, Product Release, Quality Mindset, Regulatory Compliance , USDA Regulations, Vendor AuditsPreferred Skills: ... etc. - Performs GMP walk through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements Assistance with external audits… more
- BioAgilytix (Durham, NC)
- …and rule-based checks to identify data discrepancies in real-time, enhancing regulatory compliance and minimizing errors.Independently design and configure basic ... that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data… more
- Genmab (NJ)
- …and adherence to corporate complianceCurrent working knowledge of US-specific legal, regulatory , and compliance regulations and guidelines relevant to industry ... a Director, HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate,...work with integrity-we do the right thingOversee direct report compliance with the Genmab Code of Conduct, guidelines and… more
- Eisai, Inc (Nutley, NJ)
- …of commercial call logs and HCP payment records Serve as the operational lead for Eisai US's Compliance Monitoring Program, managing internal resources and ... including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program enhancements C ontribute to… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance and Instrumentation Technician is responsible for providing equipment troubleshooting ... maintain and repair instrumentation/controls.- All duties must be performed in compliance with established company, department, and safety policies and procedures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …outcomes. Are you ready to realize your potential? The Position The Regional Lead of State Government Affairs sits within the State Government Affairs Team. This ... organizations that could negatively affect our business or patients. The Regional Lead is accountable for relationships with state level appointees within an… more
- Cox Barton County Hospital (Lamar, MO)
- …The lead pharmacist also takes on additional responsibilities, including regulatory compliance and clinical initiatives, and may assume the pharmacy ... Description :Job Summary The lead pharmacist serves as the team lead and Pharmacist-in-Charge (PIC) for a designated pharmacy group, providing daily direction… more
