- Merck & Co. (Rahway, NJ)
- …market authorization, execute of post marketing commitments and meet compliance obligations.Qualifications and Skills:Required: Global Regulatory experience ... will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS)...implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory … more
- Merck & Co. (Rahway, NJ)
- …Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Merck & Co. (Upper Gwynedd, PA)
- …and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation ... Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical Process… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare , with leading businesses and products in diagnostics, medical...and approval requirements. Participate in risk benefit analysis for regulatory compliance . Assess the acceptability of documentation… more
- Boston Scientific (Marlborough, MA)
- …solutions that improve the health of patients around the world. The Principal, Global Compliance Audit and Monitoring reports directly to the Associate Director, ... Global Compliance Audit & Monitoring. This role...activities related to the Code of Conduct and relevant regulatory risks. *Present project and program updates, analysis, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Global Biologics Operations (GBO) organization is responsible for manufacturing and supplying commercial biologic products that support over $30 ... before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the Head of Global ... Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs, as well as, the GBO Leadership Team… more
- Eisai, Inc (Nutley, NJ)
- …company. This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads ... components. Key Responsibilities:Manage and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement… more
- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Sotera Health Services, LLC (Itasca, IL)
- …oversees the quality system and uses a risk based approach to ensure regulatory compliance for Nelson Labs. Department processes include function support, ... lab experience CQA or equivalent ASQ certification preferred Essential job functions: Regulatory Compliance Know and follow applicable regulatory … more
- GRIFOLS, SA (Clayton, NC)
- …? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and ... Perform other duties as required. Additional Responsibilities, Knowledge, Skills and Abilities: Global Regulatory CMC Experience is preferred. Ability to work… more
- Abbott (San Diego, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... initial product concepts and recommend future strategies and actions. Develop and update global regulatory strategies based on regulatory changes. Conduct … more
- BillionToOne (Union City, CA)
- …with visibility into quality program status, risks, and outcomes Balance regulatory compliance with operational efficiency and speed-to-market Lead additional ... passionate innovators who wake up every day determined to transform healthcare . At BillionToOne, we've built something extraordinary-a culture where transparency… more
- CorDx (Atlanta, GA)
- … projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements. The Associate Manager will work cross-functionally with ... teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle. Key Responsibilities: Assist… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
- Abbott (Santa Clara, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare , with leading businesses and products in diagnostics, medical...submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance . Premarket: Assess the acceptability of… more
- Kenvue (Summit, NJ)
- …Responsibilities: Lead and manage global package testing laboratories, ensuring compliance with regulatory and industry standards. Lead supplier (direct as ... with innovation and design teams to ensure testing enables speed and compliance across early-stage prototyping to commercialization. Establish global governance… more
- Takeda Pharmaceutical Company Limited (Cambridge, MA)
- …Expertise: Comprehensive understanding of the pharmaceutical industry and medical affairs Global regulatory expertise with demonstrated strong ability for ... best of my knowledge. Job Description Role Objectives: The Group Lead, Global Scientific Communications has ultimate accountability for delivering and executing TA… more
- Rhythm Pharmaceuticals (Boston, MA)
- Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare ... untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize...Opportunity Overview Rhythm is looking for a Manager, QA, Global QMS in our Boston or Amsterdam office to… more
- Brenntag AG (Houston, MN)
- …to lead our comprehensive international trade operations and regulatory compliance programs across Brenntag Specialties global chemical distribution network. ... Drive continuous improvement methodology in key areas of service, profit, and regulatory compliance specific to chemical distribution. Reporting & Stakeholder… more
- Global Technical Talent (Gretna, LA)
- …Medical Insurance Vision Insurance Dental Insurance 401(k) Retirement Fund About the Company: Global Healthcare Innovator We're a leading healthcare company ... lives. Join our team and: Work on cutting-edge projects Contribute to global healthcare advancements Experience diverse cultures and geographies Discover a… more
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