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...
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...
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...
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...
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...
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...
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. ...
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...
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...
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...
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...
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...
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...
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...
Maintain single source of truth for status of all Regulatory roles being hired in India throughout recruitment, transition, and sustainment phases . Coordinate activities with Accenture and Regulatory transition team being built in India. ...
Responsible for reporting monthly adjustments and corrections to the Compliance Manager. ...
Job Title: MFG Compliance Specialist. The specialist should be able to independently influence peers to achieve a common goal. ...
The successful candidate will partner with internal and external stakeholders, including vendors and third-party assessment organizations (3PAOs), to ensure remediation is completed, controls are implemented and documented in accordance with FedRAMP compliance standards, and SLAs are met. Perform co...
Director of Regulatory Affairs Body Contouring and Regulatory Innovation MPS. Directs and supports development of the regulatory strategy related to MPS activities for device regulatory activities in a variety of counties including but not limited to US, EU, US, Japan, and China. Supports regulator...
The Compliance Manager will ensure that manufacturing processes are executed in compliance with regulations and standards. The Compliance Manager is responsible for driving cGMP quality improvements and leading complex investigations on manufacturing quality events. The Compliance Manager is an indi...
This position is responsible for managing all aspects of the company's domestic and international income tax compliance. Coordinate with the tax accounting team to ensure efficient integration of the tax accounting and international tax compliance processes. Communicate with foreign controllers/mana...
We are seeking a skilled Technical Program Manager (TPM) with at least 2 years of experience in a similar role to oversee and manage projects in our on-site testing lab. Monitor and analyze lab metrics, providing regular updates and comprehensive reports to the Lab Manager on a weekly and monthly ba...
Director of Regulatory Affairs Body Contouring and Regulatory Innovation MPS. Directs and supports development of the regulatory strategy related to MPS activities for device regulatory activities in a variety of counties including but not limited to US, EU, US, Japan, and China. Supports regulatory...
Job Title: Manufacturing Compliance Specialist. The specialist should be able to independently influence peers to achieve a common goal. ...
Director of Regulatory Affairs – Body Contouring and Regulatory Innovation MPS. Directs and supports development of the regulatory strategy related to MPS activities for device regulatory activities in a variety of counties including but not limited to US, EU, US, Japan, and China. Supports re...