- Cytiva (Miami, FL)
- …providing quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading root cause analysis ... Quality Leader and is part of the Quality and Regulatory Affairs Team located in Shrewsbury, MA. and will...in a regulated industry (ISO 9001, medical device, or pharmaceutical preferred).Experience with root cause analysis, CAPA management, and… more
- Stryker (Cary, IL)
- We are currently seeking a **Principal Regulatory Affairs Specialist,** ( ** Pharmaceutical Products** ) to join our **Medical** Division. This is a Hybrid role ... Cary, Illinois. **What you will do** As the **Principal Regulatory Affairs Specialist,** you will play a pivotal role...play a pivotal role in shaping and executing global regulatory strategies for drug development and lifecycle management. This… more
- AbbVie (North Chicago, IL)
- …deliverables including specifications and testing protocols that can stand up to regulatory scrutiny. Pharmaceutical experience strongly preferred. + 6+ years of ... documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality… more
- Takeda Pharmaceuticals (Lexington, MA)
- …therapies and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout ... as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA… more
- Bausch Health (Bridgewater, NJ)
- …assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and ... products. Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus… more
- Cardinal Health (Lincoln, NE)
- …Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + Product Lifecycle Management + ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- Boehringer Ingelheim (Ridgefield, CT)
- …on developments in the assigned therapeutic area from the global regulatory , scientific, pharmaceutical , pharmacovigilance, market access and commercial ... apply for the position in Germany, please use this link: Global Regulatory Strategy Lead - CNS, Retinal Health & Emerging Areas (boehringer-ingelheim.com)… more
- Bausch Health (Bridgewater, NJ)
- …of assigned portfolio. Active member of the product development team to provide regulatory guidance for pharmaceutical products. Manages relevant regulatory ... strategy components and interactions with Regulatory Authorities for pharmaceutical products. May perform due diligence efforts on new product opportunities. Key… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays ... with business objectives and drive the timely delivery of high-quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory … more
- Bausch Health (Bridgewater, NJ)
- …and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned brand products. Supports for Brand ... Key Responsibilities: + Provide support for the execution of the pharmaceutical regulatory brand strategy for assigned products + Support regulatory … more
- Chiesi (Boston, MA)
- …ad-hoc or special regulatory projects as needed. Experience Required + Pharmaceutical Regulatory Affairs certification preferred. + 2 + years of experience ... self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a...we are looking for Purpose Currently seeking for a Regulatory Affairs Specialist to support preparation of CMC related… more
- Merck (De Soto, KS)
- … Affairs, Global Communications, Licensing Law, Medical Device Regulations, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project ... a minimum of 3 years of USDA or FDA regulatory experience in the vaccine or pharmaceutical industry. + Knowledge of USDA requirements and regulations relating… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and SOP authoring/coordination (Required) + 3 or more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...around rare diseases and immune disorders **Job Summary:** The Regulatory Process Manager will be a key member of… more
- Bausch Health (Bridgewater, NJ)
- …writing CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and ... PhD or PharmD) preferred. + 8+ years of relevant experience in pharmaceutical labeling/ regulatory experience. + Thorough understanding of scientific principals… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- … regulatory experience. + Minimum 4 years of related technical and/or regulatory experience in pharmaceutical industry + Experience with the pre-clinical, ... experience. + Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an...of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …(eg, Pharmacy, Chemistry, Biology). + Preferred two (2) years related technical and/or regulatory experience in pharmaceutical or blood industry. + Depending on ... and services in more than 110 countries and regions. **Summary:** Plasma Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities… more
- AbbVie (Waltham, MA)
- …years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (eg, other R&D role or specialized training). ... global regulatory strategies. + Preferred Experience: 10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …ICH guidelines; + cGMP standards; + Federal and State laws related to pharmaceutical regulatory affairs; + Business, scientific and personal computer software ... Pharmacy, Pharmaceutics or a related field and 3 years of regulatory experience with a pharmaceutical company. Must have experience with: + Regulatory … more
- Abbott (Plymouth, MN)
- …life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical , In vitro diagnostic devices and/or ... with their lives. **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Electrophysiology Division on-site in Plymouth,… more
- AbbVie (San Francisco, CA)
- …R&D, or Industry-related experience. + Preferred Experience: 2-3 years in pharmaceutical regulatory activities + Demonstrates excellent negotiation skills, ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, RA Global Regulatory Strategy, US & Canada position is responsible for the development… more
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