A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports...
Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project Leaders in support of business needs. Develop and maintain positive rapport and working relatio...
The Manager, Regulatory Affairs Advertising & Promotion will serve as a facilitator on Insmed's Commercial Review Committee and be a member of the committee. Represent Regulatory Affairs on Insmed's Commercial Review Committee providing coordination and meeting facilitation. Minimum of 1 year's ...
As the Manager of Regulatory Affairs, this role advises the research, creative, application and commercial departments or customers on the safe use, regulatory compliance, regulatory strategy or advocacy for ingredients and products. In a regulatory landscape that is continuously evolving and with o...
A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports...
Regulatory Affairs Manager/Personal Care-Princeton. Regulatory Affairs Manager/Personal Care. As a Regulatory Affairs Manager North America (NA), you will be part of a cross-functional team located in North America, working closely with a Global team in Switzerland. Lead and manage NA regulatory act...
Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicab...
The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. A minimum of 4 years in IV...
Represent Regulatory Affairs on Insmed’s Commercial Review Committee providing coordination and meeting facilitation. Minimum of 1 year’s relevant work experience in Regulatory Affairs. Reviews current policies/practices and guidelines issued by Federal regulatory agencies and update management as n...
Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...
A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports...
Manager/Associate Director, Regulatory Affairs Strategist. Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development...
A Manager is responsible for activities related to regulatory publishing and submission support to FDA and other regions accepting eCTD. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications. Supports...
Our client, a growing pharmaceutical company, has engaged GForce to provide a CMC Regulatory Affairs Manager Consultant. The role will be focused on providing CMC regulatory strategy input and expertise around investigational, new, and marketed biologic and small molecule drug products to assigned p...
The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. A minimum of 4 years in IV...
Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...
The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. A minimum of 4 years in IV...
Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicab...
Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus). Responsible for determination of regulatory and scientific/technical requirements for CMC and GMP related su...
The Regulatory Manager also develops and implements regulatory strategies to support innovation projects and works in anticipation of regulatory developments with the potential to affect the current portfolio and future pipelines. The Regulatory Manager is responsible for assuring that Nestlé Health...
Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project Leaders in support of business needs. Develop and maintain positive rapport and working relatio...
The Sr GPRM works under limited supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s). Provides input to global program regulatory strategy, includin...
Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project Leaders in support of business needs. Develop and maintain positive rapport and working relatio...
Regulatory Affairs Manager - Permanent - Bridgewater, NJ. 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 introducti...
Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS) and MHRA Integrated Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools and an EDMS system. Assist with the development of assigned regulatory opera...