- Haleon (Warren, NJ)
- …will be to provide a systematic review and categorization of archived Food and Drug Administration ( FDA ) regulatory correspondences and other documents. This ... record of regulatory correspondence is critical: + Facilitates compliance with FDA requirements + Drives efficiency by sharing learnings across programs + Allows… 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
- Pfizer (Groton, CT)
- …execution of modeling to meet scientific and regulatory requirements of the US FDA , and Drug Regulatory Agencies worldwide. + Mentor scientists in ... for the department, while also influencing external scientific and regulatory practices through publication and other interactions. **ROLE RESPONSIBILITIES** +… more
- Boehringer Ingelheim (Athens, GA)
- …with developing drug product development timelines. + Familiarity with EMA and FDA regulatory requirements for new drug product submissions, ideally ... to have alignment of activities with expectations of major regulatory health authorities such as FDA -CVM and...drug products including a high-level understanding of the regulatory , quality and clinical requirements. + It will require… more
- 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 (Plainsboro, NJ)
- …Promotion + Gain understanding of how prescription drug clinical studies, regulatory strategy, and FDA -approved labeling affect promotion and advertising. + ... the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing... on Form 2253. + Learn the importance of regulatory intelligence to help inform the prescription drug… 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
- Boehringer Ingelheim (Ridgefield, CT)
- …Fellow will: * Act as a company liaison with the US Food and Drug Administration. * Research information on regulatory CMC standards and departmental policies. ... personnel, will liaise with FDA in written communication and participate in FDA meetings on regulatory issues. Will support/assist in the preparation of… more
- CVS Health (Portsmouth, VA)
- …to address them + Communicate and educate staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, ... and compliance developments (eg, state Board of Pharmacy, DEA, FDA , etc.) for pending regulatory changes and...physician to receive hard copy of prescription and perform drug recall surveillance and reporting In this role, you… more
- BeiGene (Emeryville, 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
- 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …days per week. **Your experience and qualifications** + Requires a Bachelor's degree in Pharmacy, Drug Regulatory Affairs or a related field, and 3 years of ... Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany,...for the following: submissions of assigned ANDAs, responses to FDA Deficiency letters, Correspondences and post approval supplements to… 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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …and company objectives. + Develop strategic direction and provide leadership for all regulatory interactions with FDA /global regulatory authorities + Lead ... regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and...laws, regulations, and guidelines as they apply to US FDA for drug development and approval. +… more
- Cirtec Medical (Brooklyn Park, MN)
- …Association, ATF - Alcohol Tobacco Firearms, NRC - Nuclear Regulatory Commission, FDA - Food and Drug Administration, IATA - International Air Transport ... complex devices to market. Cirtec's expertise includes neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory… more
- Houston Methodist (Houston, TX)
- …developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the ... International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of… more
- Dana-Farber Cancer Institute (Boston, 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
- Post Holdings Inc. (Hopkins, MN)
- …Administration regulations. An extensive knowledge of food related regulations and the applicable regulatory bodies (eg - FDA and USDA). Self-motivated with the ... before, within, or after your work day. Responsibilities The Director of Regulatory Affairs and Customer Compliance is responsible for overseeing and providing… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …investigations and/or administrative actions brought against the Company with particular emphasis on FDA regulatory issues + Ensure high quality legal advice is ... matters + Provide expert advice and counsel to supported businesses concerning complex regulatory matters with a focus on FDA and equivalent regulatory … more