- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...to all appropriate departments in Formation Bio to assure compliance with applicable regulations. Remains knowledgeable about current regulations… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …capabilities through strategic vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This job ... management systems and track training completion rates to ensure compliance with safety and regulatory requirements Lead...rates to ensure compliance with safety and regulatory requirements Lead the development and delivery of training… more
- Insmed Incorporated (NJ)
- …meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all ... Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve... CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... as well as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance and auditing teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...to make a difference? The Position The Patient Safety, Compliance & GxP Operational Excellence Lead is responsible for… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of Eisai's US Ethics & ... including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program enhancements C ontribute to… more
- Insmed Incorporated (NJ)
- …responsible for creating and implementing programs that ensure workplace safety, regulatory compliance , and environmental protection for all Insmed locations.Key ... consultants for instruction in subjects relating to health and safety and regulatory compliance (laws, regulations, requirements). Ensuring the proper execution… more
- Capital One (Chicago, IL)
- Director , Information Security Officer Cybersecurity is essential to what we do at Capital One, from protecting our customers to our associates. As part of the ... the business through innovation, not a step in the compliance process. You are pragmatic and practical in your...teams within Capital One to push the envelope. As Director , Information Security Officer , yo u will lead… more
- Merck & Co. (Upper Gwynedd, PA)
- …Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5 more}Preferred Skills: Current ... science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical… more
