- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in pharmaceutical / biotech / CDMO industry in a fast-paced multi-jurisdictional high- quality regulatory environment At least 5 years of progressive people ... Position Summary The Director of Regulatory Affairsis a strategic leader responsible for directing and managing regulatory strategies for multiple pipeline and… more
- Merck & Co. (Rahway, NJ)
- …initiatives, evaluate existing workflows, and implement best practices to improve the quality , accuracy, and speed of regulatory operations activities. Perform ... Job DescriptionThe regulatory operations senior specialist supports cross-functional or departmental projects related to regulatory operations. This role will… more
- Formation Bio (New York, NY)
- … quality system, including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry ... pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA, EMA), industry standards (eg, cGMP), and company… more
- Merck & Co. (Rahway, NJ)
- …requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Aequor (Bothell, WA)
- …and matrixed project teams that may include clinical, medical, statistics, regulatory publishing and submissions, quality /CMC, medical writers, and other ... Job Title: Regulatory Affairs Contractor Work Location: Bothell, WA 98021...Request-ID#33378-1 Job Description: POSITION SUMMARY: Team is seeking a Regulatory Affairs Contractor to contribute to the development and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, ... new product support.Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and combination… more
- Aequor (Thousand Oaks, CA)
- …as the primary liaison representing the country and region with Manufacturing, Quality , Regulatory Affairs, Corporate & Local Planning, and Product Delivery ... knowledge through exposure and continuous learning Knowledge of related regulatory /industry considerations and compliance issues Experience working with large data… more
- Merck & Co. (Rahway, NJ)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements.-This position will lead ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Insmed Incorporated (San Diego, CA)
- …global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and ... completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be responsible… more
- Merck & Co. (Rahway, NJ)
- …stakeholders include our Company Manufacturing sites, External Manufacturing, R&D, Quality , Operations, Product Development groups, Regulatory Affairs, ... all of our Company divisional and local site procedures for safety, quality , and regulatory compliance- Understand the big picture, and how activities link to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process qualification, packaging and labeling. This position will interface with Operations, Regulatory , Quality Assurance, Finance, R&D, Project Management and ... Office programs.Ability to design processes that ensure compliance to sound scientific Quality by Design (QbD) principles, regulatory agency requirements and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of deviances and variances that occur during production or validationWork with Quality , Manufacturing, Regulatory , and subject matter experts to prepare for ... support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the … more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by US News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by US News & World Report, Boulder is experiencing a renaissance in biotech investment and is one of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Boston, MA)
- …established practices and procedures, including laboratory notebooks, computer files, quality and regulatory guidelines, and safety standards.Actively ... participate in conferences, industry events, and scientific forums to establish strategic alliances that augment the impact at our company and on the broader scientific community.What you will need:A Ph.D. in pharmacology or related discipline with 8+ years of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues… more
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