- Novo Nordisk Inc. (Plainsboro, NJ)
- … requirements. The ideal candidate will have a strong background in documentation management, process oversight, and regulatory compliance within the ... pharmaceutical or biotechnology industry. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations or the Director, GxP… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior Principal Scientist with expertise in microbial process development for the production ... biomolecules, including novel biotherapeutics, vaccines, and engineered enzymes.As a senior scientific leader, the successful candidate will shape strategy, drive… more
- Merck & Co. (Rahway, NJ)
- …Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Proper Documentation , Regulatory Compliance, Regulatory Requirements {+ 4 ... MES, SCADA, DCS, and OEM systems-Work with process development teams on technical development and the testing of new technologies, trialing new automation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (San Diego, CA)
- …and interpret experimental data, contributing to reports, presentations, and regulatory documentation .Maintain accurate electronic laboratory notebooks and ... of science, we're in. Are you?About the Role:Insmed is seeking a Senior Research Associate - Lab Technician with specialized expertise in supporting preclinical… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- Insmed Incorporated (NJ)
- …of regulatory submissions including INDs, NDAs/MAAs, and other required documentation . Ensuring compliance with ICH, FDA, EMA, PMDA and other international ... for patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and...activities for the company's small molecule pipeline. As a senior leader, you will oversee drug substance and drug… more
- Insmed Incorporated (NJ)
- …you?About the Role:The Director, EHS (Environmental, Health, and Safety) isa senior -level role responsible for creating and implementing programs that ensure ... workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key...audits and surveys, analyze results, and provide reports to senior management and other stakeholders.Advise senior leaders… more
- Insmed Incorporated (NJ)
- …role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, ... building and protecting secure digital environments. The ideal candidate combines deep technical expertise with a proven ability to communicate complex risks in… more
- Novo Nordisk Inc. (Boulder, CO)
- …Relationships The Technical Team Lead, API Manufacturing reports to the Senior Manager, API Manufacturing. The Technical Team Lead works with Chemical ... to develop new medicines for patients. The Position The Technical Team Lead, API Manufacturing works in Novo Nordisk's...Lead, API Manufacturing acts as a delegate for the Senior Manager API Manufacturing. Essential Functions Responsible for the… more
- Merck & Co. (Rahway, NJ)
- …and documentation to meet program deadlines. - Authoring and reviewing internal technical reports, sections of regulatory filings ( eg, IND , BLA ) ... at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define… more
- Aptyx (Charlotte, NC)
- …catheters. This role is intended for candidates at the Engineer II through Senior Engineer level who are comfortable working hands on, driving technical ... in collaboration with operations, tooling, and quality teams. Prepare documentation including design history file elements, risk management documents, protocols,… more
- Cipla (Hauppauge, NY)
- …and analyze all data, write final reports and obtain approvals. Review technical documentation such as batch records, SOPs, calibration records, preventive ... English language communication skills verbally, written, and interpersonally. Must possess strong documentation and technical writing skills, and able to apply… more
- Repligen (Waltham, MA)
- …Audit, and external auditors.Communicate risks, findings, and recommendations to both technical and non- technical stakeholders, including senior ... strengthen Repligen's control environment.ResponsibilitiesKey ResponsibilitiesLead the planning, execution, and documentation of SOX IT testing activities, partnering closely with… more
- AdaptHealth LLC (Philadelphia, PA)
- Description: Position Summary: The Senior Internal Auditor - Business Systems is responsible for supporting and executing internal audit engagements, initiatives, ... while developing expertise in control evaluation, risk assessment, and regulatory compliance frameworks. Essential Functions and Job Responsibilities * Audit… more
- Cipla (Central Islip, NY)
- …Legal - Agreement and contracts. Suppliers - cost negotiation, material procurement, technical support, Regulatory docs for custom clearance, permits, approvals ... with procurement software tools, SAP, Microsoft Suite, GMP, and best documentation practices. Understanding of supply chain and inventory management systems,… more
- Parexel (Providence, RI)
- …labeling expertise into strategic impact? We're seeking a sharp, detail-driven ** Senior /Consultant, Regulatory Labeling** to join a dedicated partnership with ... go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs, Technical Operations, Safety, and Commercial. You'll help… more
- Teleflex (Morrisville, NC)
- Senior Regulatory Affairs Specialist **Date:** Dec 2, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation , and...and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.… more
- The Clorox Company (Durham, NC)
- …**Your role at Clorox:** The Senior Regulatory Specialist will ... Cosmetics Direct). ** Documentation & Communication** + Prepare and review regulatory documentation including but not limited to ingredient assessments,… more
- GRAIL (Carson City, NV)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor… more
