- 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,...from manager. Assess change controls for approved Abbreviated New Drug Applications (ANDAs), unapproved but submitted ANDAs, and make… more
- Adecco US, Inc. (Clark, NJ)
- …degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs + Experience in drug or cosmetic industry ... a local client in their search to fill a ** Regulatory Affairs Office Associate III** job opportunity located in...in US and Canada as needed + Canada Chemical regulatory oversight and review + Preparing registration documents as… more
- Catalent Pharma Solutions (Harmans, MD)
- …coordinate, and drive the development and evaluation of assigned components of new drug substance and drug product regulatory strategies and submissions ... + Conduct assessments and identify areas of improvement to regulatory aspects of drug development and commercial...areas of improvement to regulatory aspects of drug development and commercial operations; propose and implement process… more
- UPMC (Pittsburgh, PA)
- …Drug Administration (FDA) is essential. **OR** 1+ years' experience in drug development, regulatory or clinical operations functions is preferred, Exceptional ... cancer. UPMC Hillman Cancer Center is currently hiring a regular full-time ** Regulatory Specialist** to help support the Oncology Clinical Research Services team… more
- Takeda Pharmaceuticals (Exton, PA)
- …of prescription drug and biologic products. You will also provide regulatory strategic oversight for at least one complex product or therapeutic area/multiple ... preferred. + You have a minimum of 4 years' experience in drug , biologic or device Regulatory Affairs or related field, including a minimum of 2 years'… more
- MyFlorida (Tallahassee, FL)
- …Date: 02/28/2025 Total Compensation Estimator Tool (https://compcalculator.myflorida.com/) DIVISION OF DRUG , DEVICES & COSMETICS Regulatory Specialist II ... REGULATORY SPECIALIST II - 79011477 Date: Aug 29,...Cosmetics (DDC) regulates under the provisions of the Florida Drug and Cosmetic Act (Chapter 499, FS) by licensing,… more
- Novo Nordisk (Plainsboro, NJ)
- … submissions. Advertising and Promotion + Gain understanding of how prescription drug clinical studies, regulatory strategy, and FDA-approved labeling affect ... FDA on Form 2253. + Learn the importance of regulatory intelligence to help inform the prescription drug... regulatory intelligence to help inform the prescription drug advertising and promotion landscape. Physical Requirements + 10%-15%… more
- Takeda Pharmaceuticals (Columbus, OH)
- …teams and mentoring colleagues. + Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, ... the USA or more jurisdictions. + Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market… more
- Sanofi Group (Bridgewater, NJ)
- …a major market (eg US, EU, CN, JP) + Previous demonstrated experience of global regulatory drug development to at least one major regulatory approval within ... efforts in the development stage and post marketing of drug products. The Global Regulatory Lead (GRL) is the fully accountable decision maker for the… more
- Novo Nordisk (Lexington, MA)
- …advanced degree is strongly preferred + Minimum of 10 years drug development/FDA/ regulatory related industry experience required + Demonstrated knowledge ... regulatory agencies, including the FDA + Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly… more
- Haleon (Warren, NJ)
- …be to provide a systematic review and categorization of archived Food and Drug Administration (FDA) regulatory correspondences and other documents. This role ... goal. Right now, we're looking for Co-Ops student in Regulatory Affairs to join us to do career defining...components for both Investigational New Drugs (INDs) and New Drug Applications (NDAs) across the Haleon portfolio. It will… more
- Bristol Myers Squibb (Princeton, NJ)
- …, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and ... integrate one global compliance program into the Worldwide Medical, R&D and Global Drug Development Organizations . In this role, you will combine your knowledge… more
- AbbVie (North Chicago, IL)
- …expertise across CMC disciplines to further program goals via collaborations with drug product development, regulatory affairs, and commercial operations. + The ... Research Scientist II to conduct process research and development of antibody- drug conjugates from pre-clinical through clinical development. Job Description We are… more
- Lilly (Indianapolis, IN)
- …of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product manufacturing and ... commercialization or manufacturing + Demonstrated deep knowledge of the biologic drug development process. + Bioproduct Regulatory CMC experience supporting… more
- Takeda Pharmaceuticals (Lexington, MA)
- …FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory strategic oversight ... + You will have a minimum of 5 years' experience in drug , biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years' experience… more
- AbbVie (South San Francisco, CA)
- …FDA/European Medicines Agency (EMA) regulations, guidelines, policy statements, etc. for drug therapeutics. + Present pertinent regulatory information to ... and LinkedIn. Job Description Key Responsibilities + Responsible for providing regulatory strategy & support for global development. + Responsible for supporting… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical ... for the most current changes and information in the drug development space + Assess regulatory intelligence...in the drug development space + Assess regulatory intelligence information for relevance and impact to company's… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Medical Information to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director, Biologics is ... personal lives. Read more: careers.bms.com/working-with-us . The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a… more
- Englewood Lab, Inc (Totowa, NJ)
- …13485:2003). + Responsible for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings, etc), under the ... or manufacturing experience - a plus. + Experience of drug , cosmetic, medical device regulatory process is a pre-requisite Benefits + Medical, Dental, and… more
- Englewood Lab, Inc (Totowa, NJ)
- …compliance with US 21CFR 210, 211. + Maintain familiarity with changing global regulatory requirements. + Assist with CARES Act drug reporting, Product Listing ... degree (Life Sciences, Engineering, related profession). + Experience of drug , cosmetic, or medical device regulatory is...Experience of drug , cosmetic, or medical device regulatory is a pre-requisite. + Familiarity with FDA requirements… more