- Insmed Incorporated (NJ)
- …experience in interactions with FDA , EMA, and other global regulatory agenciesDeep understanding of the drug development processHighly organized with ... for documentation review prepared by other technical functions and will act as the primary regulatory contact for the US FDA . The GRL will be accountable for … more
- Formation Bio (New York, NY)
- …assesses regulatory risks associated with product development for Formation Bio's drug assets. Represents the Regulatory function on asset development teams ... supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes… more
- Merck & Co. (Rahway, NJ)
- …excellence Ensure processes align with regulatory requirements for medical device and drug combination products (eg, FDA 21 CFR Part 820, ISO 13485, ISO ... process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485,… more
- Insmed Incorporated (NJ)
- …E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs, drug development, FDA and regulatory guidelines ... (ie, PhRMA guidelines, OIG, AMA, ACCME, Sunshine Act, etc.)Global mindset with understanding of US, European, and Japanese marketsForward looking with continuous process improvement mentalityStrong strategic thinking with ability to connect multiple… more
- Syner-G BioPharma Group (Boston, MA)
- …of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology ... cGxP Quality Systems within an FDA -regulated manufacturing company.Knowledge of FDA regulations and guidance or applicable regulatory standards and… more
- AUROBINDO (Durham, NC)
- …the accuracy of analytical measurements and compliance with cGMP, US FDA , and other regulatory and corporate requirements.Conducting troubleshooting and ... and validation, with prior supervisory roles being advantageous.Familiarity with pharmaceutical regulatory standards, including USP/ICH/ FDA 21 CFR 210/211, CFR… more
- Merck & Co. (Rahway, NJ)
- …degree is preferred.Leadership experience with working knowledge of device, biologic/ drug product, and process development including regulatory submission ... & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …interpret data.Serve as the primary toxicology subject matter expert for interactions with regulatory agencies ( FDA , EMA, etc.); support or lead preparation of ... from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- … success etc.Provide expert recommendations based on scientific and medical analysis. Regulatory Compliance: Ensure adherence to FDA guidelines for 505(b)(2) ... or fellowship in a related field.Proven leadership abilities, strong knowledge of regulatory frameworks (eg, FDA ), GCP guidelines, and quality management… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Eisai, Inc (Boston, MA)
- … regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (eg, FDA , EMA, ... including but not limited to Emerging MarketsAdvance experience with the drug development process and eCTD regulatory submission standardsExpert understanding… more
- Merck & Co. (North Wales, PA)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... PreNDA-and PreBLA-meeting preparation, study data standards plan, preparing questions for FDA edata-mailboxes (CBER/CDER), attendance at meetings with regulatory … more
- Eisai, Inc (Durham, NC)
- …requirements worldwide and stay current with labeling guidelines and regulations by FDA , EMA and other applicable regulatory authorities. Represent the Global ... for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations and… more
- Insmed Incorporated (NJ)
- …including INDs, NDAs/MAAs, and other required documentation. Ensuring compliance with ICH, FDA , EMA, PMDA and other international regulatory guidelines will be ... the company's small molecule pipeline. As a senior leader, you will oversee drug substance and drug product development, analytical development, and combination… more
- Merck & Co. (Rahway, NJ)
- …our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- ... and implementation of corrective/preventative actions.-Preferred Experience and Skills:Familiarity with regulatory requirements and Good Documentation Practices (GDP).-Experience with some… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...stakeholders to ensure consistent, accurate communication of medical and drug information and Leads cross-functional and/or global initiatives in… more
- Tris Pharma (Monmouth Junction, NJ)
- …throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration ( FDA ), Drug Enforcement Administration (DEA), and ... and minimize obsolescence; Ensures compliance with safety, quality, and regulatory standards in warehouse operationsManages, coaches and mentors direct… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …global quality organization to ensure harmonization, alignment and execution of regulatory guidelines across all manufacturing areas, supporting both clinical and ... initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. This… more
- Merck & Co. (Rahway, NJ)
- …Maintain training materials in compliance with applicable SOPs, policies, and regulatory requirements. - Defines and contributes to the development of training ... experience - - Required Knowledge and skills: - Strong knowledge of drug development and clinical trial processes, including relevant standards and documentation. -… more
- Merck & Co. (Durham, NC)
- …belt certificationExperience with process risk assessment toolsExperience with responding to regulatory questions with multiple agencies (eg FDA , EMA)Experience ... activities for pipeline vaccine programs.- This is position will support vaccine drug substance site readiness and technology transfer focusing on either upstream,… more
