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...
Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings with country specific regulatory mentorship documents. The candidate will be leading the regulatory strategies for biologic products ...
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 ...
The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for as...
The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for as...
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...
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 systems and software. You proactively c...
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 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 Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on market products or those products in development. Sr Manager Clinical Affairs in the development & execution of the regulatory strategy. As...
A leading, global pharmaceutical client of ours is looking to hire a Manager of Regulatory Affairs at their prescription drug specific subsidiary, based out of New Jersey. The main function of the Manager is to provide support on writing and submitting NDAs, preparing FDA meeting requests, and worki...
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...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
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...
We expect the Manager, Regulatory Affairs CMC to join a growing team and provide support to interpret the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. May act as a submission compliance liaison with other areas of Regulatory A...
The Regulatory Affairs Manager will be responsible for ensuring compliance with all regulatory standards and guidelines, leading the preparation and submission of regulatory documents including CMC modules, and overseeing the development of generics including Risk Evaluation and Mitigation Strategie...
The Manager, Regulatory Affairs Advertising & Promotion will serve as a facilitator on Insmed’s Commercial Review Committee and be a member of the committee. Responsibilities include but not limited to the following: Represent Regulatory Affairs on Insmed’s Commercial Review Committee providing coor...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
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...
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures r...
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...
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...
Pharmaceuticals Quality/Risk Management US Regulatory Affairs. You'll serve as the primary point of contact for all regulatory responsibilities associated with assigned projects and represent regulatory function at cross function discussions. Provide strategic regulatory input to all regulatory proj...
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...
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...