Manager, Regulatory

Job DescriptionThe RA CMC Manager is responsible for the execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products.The RA CMC Manager is responsible for communicating the...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory...

Career CategoryInformation SystemsJob DescriptionThe RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is...

Role DescriptionRevio Therapeutics is seeking a seasoned Regulatory Affairs Manager with 10–15 years of experience to oversee all regulatory activities across development and registration of our 505(b)(2)/Hybrid programs. This role requires deep understanding of US FDA regulations, guidances as well as for other regulated markets. The candidate should have...

Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology,...

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and...

Company DescriptionIQEQ is a preeminent service provider to the alternative asset industry. IQEQ works with managers in multiple capacities ranging from hedge fund, private equity fund, and mutual fund launches; private equity fund administration; advisory firm set-up, regulatory registration and infrastructure design; ongoing regulatory compliance (SEC,...

Key Responsibilities:Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing .Oversee compilation and submission of Annual Reports , amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and...

Job DescriptionRoles & Responsibilities:- Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.- Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug,...

Job Title: Senior Regulatory Intelligence ManagerDescription:We are seeking a highly experienced and skilled Senior Regulatory Intelligence Manager to join our team. In this role, you will play a key part in executing our regulatory intelligence function, monitoring and analyzing the global regulatory landscape, and developing agreed intelligence...