- Merck & Co. (Rahway, NJ)
- …Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …redesign and SOP authoring/coordination (Required)3 or more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of… more
- Merck & Co. (Upper Gwynedd, PA)
- … Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... and Skills: At least five (5) years of relevant experience, including biological/ pharmaceutical research; manufacturing, testing, or regulatory CMC; or related… more
- Eisai, Inc (Nutley, NJ)
- …relations, government price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and ... standing of a state bar. Strong knowledge of FDA regulatory and fraud and abuse laws and/or pharmaceutical... regulatory and fraud and abuse laws and/or pharmaceutical government price reporting laws. Ability to learn quickly… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise in Lean ... entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize… more
- Merck & Co. (Rahway, NJ)
- …Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause ... interface between our company and our External Partners (EP) for Active Pharmaceutical Ingredients (API) and intermediates. You will be responsible for providing… more
- Eisai, Inc (Nutley, NJ)
- …orientation to identify breakthrough opportunities.Comprehensive understanding of legal and regulatory issues impacting pharmaceutical product marketing as well ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Lundbeck (Edmond, OK)
- … Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Eisai, Inc (Nutley, NJ)
- …of brand plansStrong communication and presentation skillsUnderstanding of legal and regulatory issues impacting pharmaceutical product marketing as well as ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience and 4+ ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Lundbeck (Raleigh, NC)
- …resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence ... policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Merck & Co. (Rahway, NJ)
- …should have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC, Statistical Design… more
- Merck & Co. (Rahway, NJ)
- …record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. Educational background ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Eisai, Inc (Nutley, NJ)
- …marketing, managed markets, sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory requirements ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Boston, MA)
- …within local markets and healthcare systems).Experience working with pharmaceutical manufacturer compliance & regulatory requirements.Experience networking, ... Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and...Area Business Leader- ADBachelor's degree with 10+ years of pharmaceutical , biotech, or medical device sales with 5+ years… more
- Eisai, Inc (Nutley, NJ)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the...Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the pharmaceutical industry required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Merck & Co. (Rahway, NJ)
- …selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once ... Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS).- Education Minimum Requirements:- Bachelor's… more
