A company is looking for a Regulatory Affairs Manager, US Regulatory Lead, Rare Disease. ...
Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Assist Regulatory Staff by identifying & gathering...
General Description:The Senior Manager, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives, and in coordination with key internal stakeholders. Provides ...
Global Regulatory Affairs Strategy roles (U. Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Assist Re...
We are seeking a Regulatory Affairs - CMC professional to join our team as Senior Manager, Regulatory Affairs - CMC. Regulatory professional with 5+ years of industry experience in pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, and Manufacturing or related, with ...
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. Job Title: Senior Manager, CMC Regulatory Af...
Liaise with colleagues in Regulatory Affairs therapeutics teams, Client 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, Biol...
In this role as a Regulatory Affairs Specialist, you will have responsibility for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain and expand regulatory approval of Hinge Health’s medical device portfolio. This Specialist will work with ...
Experience in California or other state or federal regulatory and government affairs. Representing and advocating for Verizon’s interests before state regulatory commissions and relevant state legislative policy committees in California and other states. Testifying before state regulatory commission...
Experience in California or other state or federal regulatory and government affairs. Representing and advocating for Verizon's interests before state regulatory commissions and relevant state legislative policy committees in California and other states. Testifying before state regulatory commission...
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...
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,...
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,...
We are seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). You will be responsible for interfacing with Regulatory Operations and CROs to support various submissions to Health Authorities, in support of investigational applicatio...
Liaise with colleagues in Regulatory Affairs therapeutics teams, Client 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 Aff...
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. Job Title: Senior Manager, CMC Regulatory Affairs, ...
Regulatory Affairs Manager – Digital Health Technology. Regulatory Affairs Manager – Digital Health Technology. Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submiss...
Closely monitor, analyse, develop regulatory priorities and coordinate positions and strategies for regulatory and market affairs in MISO and other priority markets. Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political...
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. Job Title: Senior Manager, CMC Regulatory Af...
Biogen company, is seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). Combination of the following can be considered: PhD or PharmD with 2+ years of pharmaceutical industry experience in regulatory affairs; MS with 4+ years; BS ...
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. Job Title: Senior Manager, CMC Regulatory Af...
Liaise with colleagues in Regulatory Affairs therapeutics teams, Client 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, Biol...
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. Job Title: Senior Manager, CMC Regulatory Af...
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...