The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitabl...
Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible preparing CMC regulatory strategies that enable first pass approvals. Reports to the Senior/Executive Director or Vice President, Regulatory...
Senior Director, Global Regulatory Affairs Strategy. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsibl...
Our Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and ...
The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitabl...
Our Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investi...
Associate Director, US Regulatory Affairs, Advertising & Promotion - Permanent - NJ & MA. Proclinical is seeking an Associate Director, Regulatory Affairs, Advertising & Promotion for a global pharmaceutical company with their location in New Jersey. The Associate Director, Regulatory Affairs, Adver...
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...
SPARC is seeking a Senior Director, Global Regulatory Affairs Strategist to join their team at the North American corporate headquarters in Princeton, NJ. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which in...
In this role, the regulatory leader will be primarily responsible for the development of US regulatory strategies and have the role of Global Regulatory Strategist to advance Genmab’s portfolio of development and marketed drugs. Genmab is looking for an experienced and passionate leader to be a part...
As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. The Director will also ser...
Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent experience. Quality/Risk Management Worldwide Regulatory Affairs. Johnso...
The Senior Director of Global Regulatory Opera. Full awareness pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations. Ability to influence and partner within Regulatory Affairs and with Cross- Functional teams ...
The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitabl...
Are you ready to make a difference? The Position Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible preparing CMC regulatory strategies that enable first pass approvals. Train global function...
Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation, and maintenance of US/global regulatory strategies...
Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs. The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned p...
The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required. The RA Associate Director, Labeling will be ove...
The RoleThe Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group. Senior Manager, Glob...
Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible preparing CMC regulatory strategies that enable first pass approvals. Reports to the Senior/Executive Director or Vice President, Regulatory...
Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible preparing CMC regulatory strategies that enable first pass approvals. Reports to the Senior/Executive Director or Vice President, Regulatory...
Rocket Pharma is seeking an experienced and highly motivated Director, Regulatory Affairs for AAV, who enjoys a fast-paced, dynamic work environment at the forefront of innovation. The responsibilities include providing US regulatory leadership and direction for Rocket’s gene therapy products, inclu...
The Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Implements regulatory strategies and solutions to assure all adverti...
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...
The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group. Ability to interpret Regulat...