A company is looking for a Regulatory Affairs Program Manager to lead program and operations management for regulatory affairs. ...
Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strat...
A company is looking for a Senior Manager, Regulatory Affairs IVD & CDx. ...
The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. Function as a Regulatory A...
Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. We are seeking a Senior Manager, Regulatory ...
Liaise with colleagues in Regulatory Affairs therapeutics teams, , Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. An in-depth knowledge of ICH and regional CMC regulatory requiremen...
Manager/Senior Manager of Regulatory Affairs. Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including Engineering, Product Management, Quality Compliance, Clinical Affairs and other functions at all levels within the business. Minimum of 8 ye...
The Digital Technology Manager, individual contributor, will lead the digital transformation of our Global Stewardship team, driving innovation and efficiency in regulatory processes. The ideal candidate will possess a deep understanding of digital technology, data management, and regulatory affairs...
As a Regulatory Affairs manager, you will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. Regulatory Affairs, FDA, regul...
This role’s primary responsibility is to partner with Regulatory therapy area leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions. Regulatory Affairs in the biotechnology or pharmaceutical industries. Manager will coordinate activities ...
Alternative Education and Experience Requirement: Bachelor’s degree in Medical Device and Diagnostics Engineering, Regulatory Affairs/Compliance, Biology, Chemistry, or related field of study plus 8 years of experience in IVD Regulatory Affairs or Medical Device Regulatory Affairs as a Regulatory Af...
The Manager of International Regulatory Affairs will be responsible for overseeing all regulatory aspects of devices marketed and sold in international markets, with a specific focus on OUS, Japan, China and Korea. Manager, Regulatory Affairs, International. Minimum of 8 years of experience working ...
At Roche Global Regulatory Affairs, we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more com...
Identifies growth and areas of opportunity to enhance Regulatory Affairs and AHS initiatives. Assists in all accreditation and regulatory activities, including surveys, survey preparation and readiness assessments. Finalizes corrective action responses to The Joint Commission and other regulatory ag...
The Manager, Regulatory Affairs provides support pertaining to regulatory affairs related to the development of novel drugs including preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. Interacts with the Regulatory, Clinical...
Regulatory Affairs in the biotechnology or pharmaceutical industries. Manages most aspects of company regulatory interface with domestic and international health authorities. Manages the development and deployment of the regulatory program that ensures aggressive product approval. Manages and may ge...
The Senior Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U. Extensive knowledge of regulatory requirements, including ICH and regional guidelines, and an understanding of current global and regional trends in regulatory affai...
Our partner, a leader in innovative biopharma resources and patented ingredients, is seeking a Regulatory Affairs Specialist to join their Los Angeles team. This role offers a chance to contribute to groundbreaking developments and regulatory processes with a global impact. Develop and support regul...
Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strat...
Regulatory Affairs Manager - Permanent - Remote. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and p...
The Digital Technology Manager, individual contributor, will lead the digital transformation of our Global Stewardship team, driving innovation and efficiency in regulatory processes. The ideal candidate will possess a deep understanding of digital technology, data management, and regulatory affairs...
Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, CMC Regulatory Affairs, Biologics. ...
Liaise with colleagues in Regulatory Affairs therapeutics teams, company local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, Regulatory Affairs III. Sen...
At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team is tasked with regulatory projects as well as overarching regulatory topics with specific focus in Near Patient testing. You proactively c...
Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Job Title: Senior Manager, CMC Regulatory Affairs, ...