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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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The Senior Risk analyst supports Bank responses to audit, model risk management and regulatory examinations and for all Credit Risk Stress Testing Activities and coordinates these activities with the Senior Director - Risk Analytics, the as well as the heads of Model Development, Model Implementation, and Capital Planning.
$50Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Prepare/review technical documents including development/tech transfer reports and CMC regulatory submissions - Participate on cross-functional teams to progress both early and late stage drug candidates.
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Required Experience: Must have attained or worked towards obtaining the ICB Certified Regulatory Compliance Manager (CRCM) certification. Bachelors Degree and five plus years regulatory compliance related work experience.
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This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures.
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Demonstrate protection and safety for patients and team members as outlined in department protocols and regulatory guidelines pertaining to radiation safety. Our facilities and sites of care include: Morristown Medical Center, Morristown, NJ Overlook Medical Center, Summit NJ Newton Medical Center, Newton, NJ Chilton Medical Center, Pompton Plains, NJ Hackettstown Medical Center, Hackettstown, NJ Goryeb Children's Hospital, Morriston NJ Atlantic Rehabilitation Atlantic Home Care and Hospice We also have more than 900 community-based healthcare providers affiliated through Atlantic Medical Group.
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Educates physicians regarding InterQual criteria, documentation of patient acuity and treatment plan and the related expectations of CMS, JCAHO, NYS DOH and other regulatory bodies. Specialty : RN Case Management/Clinical Liason.
$40 an hourTemporaryExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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On-Board Scientific is hiring a Nonclinical Regulatory Document and Scientific Writer based out of either New Brunswick, Lawrenceville or Summit, NJ! Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
$57.78 - $62.5Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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To provide oversight and guidance to ensure the eTMF system aligns with Eisai TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
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Direct working experience using, implementing, or supporting systems related to any of the following topics: trading, operations, lending, core banking platforms, compliance monitoring, regulatory reporting, risk or case management, or data management.
$170,912 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This role requires a deep understanding of data governance principles, data management discipline, data privacy, and regulatory compliance requirements and solutions. This will include the following key responsibilities:Stay current with industry trends, emerging technologies, and pharma regulatory changes that may impact data governance practices.
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And other applicable New Jersey regulatory agencies, including Waterfront Development, Coastal Zone Management, Coastal Area Facility Review Act (CAFRA), Natural Heritage Program (NHP), freshwater and coastal wetlands, watershed and land management (Land Resource Protection), stormwater management, New Jersey Pinelands Commission, former New Jersey Meadowlands Commission, New Jersey Flood Hazard Area Rules, marine sediment and dredging, and the Green Acres Program.
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Deliverables may include sections of individual protocols consistent with the clinical development plan (CDP), data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications (e.g., investigator brochures, briefing books, safety updates, submission dossiers, and responses to health authorities.
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Maintains knowledge of Federal, State, and other regulatory agency rules and regulations including The Joint Commission, CMS, Medicare, including but not limited to, knowledge of CMS rules regarding Observation status, the 2 Midnight Rule, and Medicare Inpatient Only Procedures.
$2,236 a weekExpandApply NowActive JobUpdated Today
regulatory job in Hanover, NJ
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