- Merck & Co. (Rahway, NJ)
- …Communication, Cross-Cultural Awareness, Data Management, Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, ... 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. (Rahway, NJ)
- …US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the operating ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory … more
- Eisai, Inc (Nutley, NJ)
- …supplementary applications in essential. Demonstrated track record of interfacing effectively with FDA , EMA and other global regulatory agencies. Experience in ... 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
- Merck & Co. (Rahway, NJ)
- …assembly processes.Extensive knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System ... in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead… more
- Merck & Co. (Rahway, NJ)
- …for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( FDA , EMA, PMDA),Guiding project teams preparing submission ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Durham, NC)
- …independently and within a team environmentPreferred:Experience with responding to regulatory questions with multiple agencies ( FDA , EMA, JNDA,).Experience ... and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and budgeting.Build… more
- Lundbeck (Fort Wayne, IN)
- … regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability ... to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA , and PDMA guidelines. REQUIRED EDUCATION,… more
- Merck & Co. (Rahway, NJ)
- …ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other ... momentum, and an inspiring mission to achieve new milestones in global healthcare . The Biologics and Biopharmaceutics team is responsible for the research and… more
- Merck & Co. (Rahway, NJ)
- …BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Eisai, Inc (San Jose, CA)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... clinical information to customers and key stakeholders consistent with the FDA -approved indication. Additionally, the Senior NAS will be responsible for ensuring… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a ... robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier...expedite receipt of incoming product through customs and the FDA . The position is also required to work closely… more
- Merck & Co. (Durham, NC)
- …certification Experience with process risk assessment tools Experience with responding to regulatory questions with multiple agencies (eg FDA , EMA) Experience ... process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments Author or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Companion Diagnostic products preferredProven experience with Health Authority Inspections, (eg, FDA , HPFB, MHRA and other European regulatory agencies) ... File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application Qualifications: Successful candidates will be able to meet… more
- Lundbeck (Waco, TX)
- …Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies ... and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or… more
- Lundbeck (Joliet, IL)
- …Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and ... procedures and FDA regulations regarding the promotion of pharmaceutical and medical...years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must demonstrate the intellectual capacity to… more
- Eisai, Inc (Nutley, NJ)
- …Claims Act, federal and state pricing-related laws and regulations, PhRMA Code and FDA regulatory guidelines.Serves as the legal representative for market access ... Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is...good standing of a state bar. Strong knowledge of FDA regulatory and fraud and abuse laws… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...equivalent role required 3 years of experience in a healthcare system preferred Direct experience in therapeutic area (Hemostasis)… more
- Eisai, Inc (Raleigh, NC)
- …functions, deviation investigation and resolution, as applicable) .Familiarity with applicable regulatory requirements (eg, FDA , EMA, ICH) and quality ... 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
- Eisai, Inc (Boston, MA)
- …systems).Experience working with pharmaceutical manufacturer compliance & regulatory requirements.Experience networking, establishing, and maintaining strong ... 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
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
