- Novo Nordisk Inc. (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. ... including hands on related pharmaceutical or medical device/pharmaceutical combination product experience and actual regulatory experience Advanced knowledge… more
- Catalent (Manassas, VA)
- …revised SOPs and guidance pertaining to Regulatory Affairs and regulatory compliance . Will prepare for and lead regulatory meetings, designing ... Associate Director, Regulatory Affairs is to support regulatory strategy for product development and manufacturing...regulatory compliance strategy to ensure compliance with GMP regulations, assisting in training of … more
- Aequor (Newbury Park, CA)
- …Utilize the Six Sigma method to support team processes. As the Global Labeling Lead product lead for marketed products, leads product -specific ... instructions/guides, since we work in a framework based on rules/ compliance . Education background preferred for this role: Science/Technology-based degrees are… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What ... Environmental, Health, and Safety (EHS) initiatives with a focus on environmental compliance and reporting. Priority reports include air permitting, Tier II &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we embark on shaping our future. The Position The Senior Manager - New Product Commercialization (NPC) and 5D will lead and execute strategic and tactical ... compelling personal and non-personal promotional tactics in support of market shaping and product launch efforts Lead innovation efforts to support rare disease… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations as ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and tracking of quality metrics while ensuring high quality and complaint product supply. Key Responsibilities Support compliance activities for site Quality ... immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Lead as part of the Quality team based in Raritan, NJ. Role Overview… more
- American Honda Motor Co Inc (Marysville, OH)
- …want you to join our team to Bring the Future!Job PurposeManage environmental regulatory compliance (CAA, CWA, RCRA, EPCRA, SWPPP, SPCC) and sustainability ... systems updates to ensure needed data is available for regulatory compliance and sustainability reporting objectives. Key...at their end of life (EOL) with triple zero mindset. Lead meetings with customers and contractors of all levels… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Agreements, FDA safety reporting guidelines and Good Clinical Practice (GCP) to ensure adherence/ compliance Lead and author updates to NAO Patient Safety SOPs ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …floor. Essential Functions Reviews all manufacturing and support records to certify compliance with specifications and procedures Releases product based on ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI… more
- Merck & Co. (Durham, NC)
- …performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).-Continuous Improvement - Accountable for ... start-up experienceDemonstrated experience of interacting with site, divisional or regulatory auditsCore Skillsets Ability to develop and lead othersAbility… more
- Eisai, Inc (Nutley, NJ)
- …a biopharmaceutical manufacturer capacity)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated success in leading ... multidisciplinary matrix team within EisaiAdvanced understanding of pharmaceutical manufacturer compliance & regulatory requirementsAbility to operate a motor… more
- Merck & Co. (Rahway, NJ)
- …leadership and input in key opinion leader engagement execution, target product profile development, health authority interactions, global regulatory filing ... development experience.Experience providing commercial input on such activities as:target product profile (TPP) development, global regulatory filing strategy,… more
- Lundbeck (Knoxville, TN)
- …Join us on our journey of growth! As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Catalent (Philadelphia, PA)
- …material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA ... expert for "Good Manufacturing Practices" and "Good Distribution Practices"Act as lead investigator for all compliance issues regarding incoming, distribution,… more
- Merck & Co. (Durham, NC)
- …site procedures to resolve process/equipment issues, minimize downtime, and ensure product quality.- This role actively supports, participates, and embraces an ... on time approval of payroll activities using site approved software like ADP. Lead and support daily meetings to facilitate flow of information up/down through… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to ensure product reliability, quality, efficacy, and complianceOversee compliance auditing program to fulfill regulatory requirements.Follow applicable ... policies, and practices to ensure Quality Assurance and GxP compliance , and lead a quality culture within...procedures.Manage strategy and approach for all inspection/ audits in compliance with local and global regulatory agencies.Respond… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Catalent (Harman, WV)
- …with regulatory requirements/expectations.Interface with all other departments to ensure compliance with cGMP.Monitor site compliance to FDA, EU and all ... other applicable requirements.Analyze, resolve, or assist in solving compliance and customer issues.Ensure regulatory and customer audits are managed… more
