- Novo Nordisk Inc. (Plainsboro, NJ)
- …global regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead health authority interactions, ... Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to… more
- Merck & Co. (North Wales, PA)
- …with vaccines, biologics, and / or cell gene therapy productsTechnical Operations , Quality operations and/or compliance experienceDemonstrated effective ... Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good...the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations , Non-clinical, Clinical, and other ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Novo Nordisk Inc. (Boulder, CO)
- …2021 to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development ... disruptions to our patients Work effectively across all departments, such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , … more
- BioAgilytix (Durham, NC)
- … frameworks, including FDA, GLP, GxP, and Part 11.o Partner with BioAgilytix's Quality and Regulatory teams to support validation, documentation, and audit ... upgrades, and escalations as needed.o Collaborate with cross-functional stakeholders, including lab operations , IT, and quality control teams, to prioritize and… more
- Novo Nordisk Inc. (Boulder, CO)
- …2021 to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk Inc. (Boulder, CO)
- …2021 to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Merck & Co. (Rahway, NJ)
- …teams while interfacing with other functional areas (eg project management, manufacturing, quality , regulatory affairs) and external partners to drive project ... experimental design & data analysis, authoring of technical reports, regulatory submissions and patent applications. -Active participation on formulation development… more
- Merck & Co. (Rahway, NJ)
- …and serves as Quality spokesperson, on a variety of Quality or compliance-related issuesInterprets complex regulatory requirements for various audiences, ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and process qualification, packaging and labeling. This position will interface with Operations , Regulatory , Quality Assurance, Finance, R&D, Project ... Office programs.Ability to design processes that ensure compliance to sound scientific Quality by Design (QbD) principles, regulatory agency requirements and… 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)
- …coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (eg Protocol Amendments, ... regulatory is preferred)Daiichi Sankyo, Inc. is an equal opportunity /affirmative action employer. Qualified applicants will receive consideration for employment… more
- Merck & Co. (North Wales, PA)
- …for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance ... Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… 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 ... centered around rare diseases and immune disorders.Summary This role offers the opportunity to substantially contribute to the mission of Daiichi Sankyo in… more
- AUROBINDO (Dayton, OH)
- …management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... and investigations under the direction of a supervisor.8. Comply with all regulatory /in-house requirements (may include but not limited to safety, house keeping,… more
- AUROBINDO (Dayton, OH)
- …management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... and investigations under the direction of a supervisor.8. Comply with all regulatory /in-house requirements (may include but not limited to safety, house keeping,… more
- Merck & Co. (Rahway, NJ)
- …the functions that support the business including the following: Technology, Manufacturing Operations , Finance, Regulatory , Quality , Compliance, Supply Chain ... years of relevant work experienceIn-depth and wide breadth of experience in operations , technology, quality , and/ or supply chain.Demonstrated record and proven… more
