- 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. (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
- 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
- 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
- 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. (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)
- …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 ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… 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 ... to coordinate planning, implementation, documentation and support manufacturing and laboratory operations and plant facilities. The role has to coordinate with all… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …risks and vulnerabilities, applying expert knowledge of compliance with all security, regulatory , and quality policies and procedures, ensuring compliance with ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
- Merck & Co. (Durham, NC)
- …have an exciting opportunity for a Specialist to join the technical operations team supporting a capital project critical to Human Health at our facilities in ... of both drug substance and drug product, including product inspection, and quality control laboratories.The Specialist, Technical Operations will be responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of ... strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.Has… more
- Merck & Co. (Durham, NC)
- …team meetings HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations , lean six-sigma, quality , safety or environmental training/initiatives as ... and teamwork.- As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding… more
