- 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...marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post ... approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders...assessments, and coordinating with regional RA-CMC leaders to formulate regulatory strategies for post-approval changes. This role will also… more
- Insmed Incorporated (San Diego, CA)
- …each other, 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 ... identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global ... regulatory strategies and plans to enable efficient, competitive product...product development for assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director , Regulatory Affairs, Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... is preferred and remote working possible **Location: Remote** **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices. All… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage NA … more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in ... candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well… more
- Merck & Co. (Rahway, NJ)
- …laboratories, and for maintaining a state of inspection readiness at all times. The Director should be well engaged with regulatory and industry trends and have ... Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional,… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** This role is the head of Promotional Regulatory , and provides regulatory leadership, support, oversight, and strategic guidance on ... States with some activities globally to ensure compliance with applicable regulatory requirements and guidelines, and consistency with approved labeling. The role… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are 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 duties include risk… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning ... plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Associate Director , Programming provides technical leadership and ensures adequate programming support for ... Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory , and Clinical Development, as well as with external vendors.… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Senior Director , Medical Services will provide strategic leadership to Insmed's independent medical ... strategies to fill core educational and research gaps. The Senior Director , Medical Services will drive operational excellence and continuous process improvements… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and process improvement ... training, and data-driven optimization aligned with Insmed's strategic goals.The Associate Director , Patient Services Quality & Process is responsible for overseeing… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Regional Business Director will help recruit, hire, develop, and lead his/her sales team in hematology for ... all sales goals while maintaining compliance with field sales activity. The Director will develop the business plan for their geography and implement… more
- Insmed Incorporated (NJ)
- … regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a critical leadership role in ... ensuring alignment with the company's values, business priorities, and regulatory commitments.Present cybersecurity posture, emerging threats, and key initiatives to… 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
- 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
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems...industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems… more
