- Stanford Health Care (Palo Alto, CA)
- …front-line staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug ... Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs,… more
- Novo Nordisk (Lexington, MA)
- …required/an advanced degree is strongly preferred + Minimum of 10 years drug development/ FDA / regulatory related industry experience required + Demonstrated ... leading meetings with regulatory agencies, including the FDA + Experience with rare disease drug ...the FDA + Experience with rare disease drug development, innovative trial design and/or expedited regulatory… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior Director of ... updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs/ FDA Communications in managing, coordinating, tracking and… more
- MD Anderson Cancer Center (Houston, TX)
- …employees and the public. This position will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational ... all regulatory submissions in accordance with applicable regulatory requirements. Acts as the liaison between FDA...Ten (10) years of progressive experience in clinical research, regulatory affairs, and drug development. Experience in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External ... regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RA...regulatory trends and developments for their impact on drug development activities and on existing development strategies. +… more
- BeiGene (San Mateo, CA)
- …negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to...in the oncology therapeutic area. + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… more
- BeiGene (San Mateo, CA)
- …negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of ... of department policies. **Responsibilities:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both… more
- Cordis (Irvine, CA)
- …in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral ... to remote. MedAlliance (Cordis) are seeking a highly skilled and motivated Principal Regulatory Affairs Specialist to join our dynamic team. This role will play a… more
- University of Washington (Seattle, WA)
- … agencies, including the Institutional Review Board, the Food and Drug Administration ( FDA ), the Institutional Biosafety Committee, the institutional ... prioritization of all regulatory affairs to ensure timely submissions to regulatory bodies (IRB, FDA , sponsor, etc.). * Oversee, coordinate, and implement… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … submissions. **Responsibilities** + Actively leads development and implementation of regulatory strategies for assigned early drug development programs ... Document (eCTD) format. + Experience with international clinical trials and regulatory documentation. + Experience interacting with FDA representatives and… more
- Novo Nordisk (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...is also responsible for maintaining product and establishment registrations ( drug /establishment listings) and submission to FDA databases.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... strategy for assigned project(s). Strategize and plan for FDA meetings. + Serve as the primary contact with...in regulatory affairs + Experience in providing regulatory strategic input into the drug development… more
- Ascendis Pharma (Princeton, NJ)
- …with prescription drug , biologic, and/or combination products; experience managing major regulatory filing(s) to the FDA Office of Prescription Drug ... regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …enforcement letters) or competitor complaints. + Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and ... regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory strategic oversight for… more
- Lundbeck (Deerfield, IL)
- …products. + Acts as FDA contact for assigned products. Liaises with regulatory authorities for all drug development and approval aspects. + Manages the ... + Provides regulatory review of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Manages,… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …reports, to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, ... documents for SRC and IRB review and approval. + Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive… more
- Amazon (Bellevue, WA)
- …or external regulatory authorities. * Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and...dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) - . Drug … more
- Takeda Pharmaceuticals (Lexington, MA)
- …responses to enforcement letters) preferred. + Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and ... where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion...drug and biologic products. You will also provide regulatory strategic oversight for at least one complex product… more
- BeiGene (Emeryville, CA)
- …companion diagnostic products supporting development and approved products, ensuring compliance with regulatory agencies such as the FDA , EMA, and other health ... Risk Management: + Ensure all companion diagnostic products comply with applicable global regulatory requirements and standards (eg, FDA , EMA, ISO, etc.). +… more