- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management ... (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory… more
- PSG Global Solutions (Cambridge, MA)
- Description We're looking for a Manager of Regulatory Affairs , working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States. ... Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of any required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team ... for a living. Are you ready to make a difference? The PositionThe Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program… more
- Eisai, Inc (Exton, PA)
- …Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the ... preparation of CMC regulatory submissions that meet global regulatory requirements, represent CMC regulatory at team meetings. Participates in identification… 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
- Hinge-Health (San Francisco, CA)
- About the RoleIn this role as a Regulatory Affairs Specialist, you will have responsibility for developing and influencing regulatory policy and determining ... to engage, coach, and teach cross-functional team members regarding Regulatory Affairs and medical device requirements.Preferred QualificationsFamiliarity with… more
- Oil-Dri Corporation of America (Vernon Hills, IL)
- …Hills, Illinois, United States of America Req #1712Friday, May 3, 2024Job Overview:The Regulatory Manager will be instrumental in helping to ensure the company ... meets all compliance requirements while achieving critical deadlines for key regulatory demands. This includes the management and preparation of various critical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical ... adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate… 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)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to, ... areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term plans,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …areas during their rotations. Additional key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning & Development, ... Essential Functions Fellow will collaborate with cross-functional areas including Medical Affairs , Regulatory Affairs , Marketing, etc. This structured… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Education throughout the one-year program. Additional key internal relationships include Medical Affairs , Marketing, Legal and Regulatory Affairs . Other ... internal relationships include managed care, trade, government affairs and global marketing.External relationships include relations with key opinion leaders,… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors adherence… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the ... ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are… more
- Vertex Pharmaceuticals Incorporated (Boston, MA)
- …Access, Global, International Medical Affairs organizations, US Public Affairs , Corporate Communications, Legal, Compliance (OBIE), Regulatory , Research & ... Job DescriptionGeneral Summary:The Medical Affairs Medical Director, Hematology - US will provide medical leadership for the Medical Affairs Department in our… more
- Vertex Pharmaceuticals (Boston, MA)
- …Additionally, this role interacts regularly with multiple Global Medical Affairs functions, including regional and country medical colleagues, Medical Communication, ... as multiple other internal functions including Commercial (marketing, sales), Regulatory , Clinical Development, Biometrics, and Safety. Key Responsibilities: Develops… more
