- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Job Description Exciting opportunity at MSK: Join our team as aResearch Regulatory Associate ! We're looking for a dynamic clinical research professional ... to support our Early Drug Development service, MSK's phase 1 research team ....Role Overview: + Perform all tasks associated with the regulatory management of research protocols within MSK. + Responsible… more
- Amgen (Washington, DC)
- …**Or** Bachelor's degree and 6 years of experience in regulatory or pharmaceutical drug development **Or** Associate 's degree and 10 years of experience in ... on US regulatory mechanisms to optimize product development (eg orphan drug , fast track, early access, pediatric plan) + Exchange regulatory information… more
- Ascendis Pharma (Princeton, NJ)
- …governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs, Advertising and Promotion is responsible for ... together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs, Advertising and Promotion...have a minimum of 8 years of experience in drug , biologic and/or combination products in Regulatory … more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director, US Advertising & Promotion Regulatory Review** **Takeda ... Exton, PA** **About the role:** Join Takeda as an Associate Director, US Advertising & Promotion Regulatory ...guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory … more
- Boehringer Ingelheim (Ridgefield, CT)
- …lives? Boehringer Ingelheim is seeking a dedicated and innovative Director/Senior Associate Director, Global Regulatory Affairs CMC for Chemical products ... to the continuous improvement of processes and standards within Regulatory Affairs. If you have a strong background in...for our employees. The GRL CMC Director or Senior Associate Director has responsibility for the strategic global CMC… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: + Assist the Manager of ... Regulatory Affairs for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings, etc.), under the… more
- Organon & Co. (Plymouth Meeting, PA)
- …Organon Regulatory Chemistry, Manufacturing and Controls New Products, the Associate Principal Scientist ( Associate Director) is responsible for ... molecule products in accordance with global regulations, guidance's and defined regulatory strategies. These products may be internal or acquired or licensed… more
- ICU Medical (Lake Forest, IL)
- *Position Summary* The Regulatory Affairs Associate will assist with 510(k) submissions,International Licensing and Submissions, and respond to routine ... regulatory queries for information and documents. The Regulatory Affairs Associate will also complete International...regulatory agencies such as the Federal Food and Drug Administration, Canada, SUKL, etc. Ensure that all products… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will define, ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- Boehringer Ingelheim (Ridgefield, CT)
- … leadership to the global and US cross-functional teams. Provide US strategic regulatory guidance to facilitate efficient and compliant drug development and ... as primary company liaison with the US Food and Drug Administration + Provide analysis, advice and guidance on...Administration + Provide analysis, advice and guidance on US regulatory strategies. + Provide expertise on regulatory … more
- Takeda Pharmaceuticals (Columbus, OH)
- …company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - GI2 TAU ... teams and mentoring colleagues. + Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance,… more
- Kemin Industries (Des Moines, IA)
- Overview Our Food Technologies team is hiring a Regulatory Affairs Associate ! In this role, this person will be responsible for preparing regulatory ... such as amendments, supplements, and annual reports in accordance to local regulatory requirements. In addition, they will accurately populate and maintain the… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and ... drug -device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on...project management skills as evidenced by past performance on drug development project teams + Ability to thrive in… more
- Sumitomo Pharma (Columbus, OH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs** . The Associate Director is ... the US. He/she will primarily function as a Regional Regulatory Leader (RRL) and is responsible for ensuring the...(ROL), ensures all submissions to the Office of Prescription Drug Promotion (OPDP) are complete and presented to facilitate… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Salary Range: Dependent on Qualifications/Experience Position Summary/Description: The purpose of Regulatory Associate is to facilitate the conduct of oncology ... clinical trial management system (OnCore) and eRegulatory binder (Florence). The Regulatory Associate also includes involvement in process improvements and… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Lead, GI & Inflammation where you will ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- Capital One (Richmond, VA)
- …Creek 3 (12073), United States of America, Richmond, Virginia Senior Accounting Associate , Regulatory Reporting Capital One has an exciting opportunity within ... the Regulatory Reporting team. We are looking for someone with...of financial information submitted to US regulators. The Senior Associate role will gain a deep understanding of Capital… more
- BeiGene (Emeryville, CA)
- **General Description:** The Associate Manager, Regulatory Project Manager, is responsible for providing regulatory project management support, to the ... discipline. PMP or similar certification preferred. + Working knowledge of drug development and regulatory agency regulation, guidelines, and submissions.… more
- American Heart Association (Washington, DC)
- …career. The **American Heart Association** has a phenomenal opportunity for an ** Associate ** ** Regulatory Affairs Manager** with our Federal Advocacy Team in ... work arrangements available. Under the direction of the Director, Federal Regulatory Affairs, you would be responsible for monitoring, analyzing, and drafting… more