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...
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...
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 ...
Support the development of regulatory strategy and update strategy based upon regulatory changes. Manage the regulatory activities for multiple projects simultaneously and respond readily to changing events and priorities. Ensure timely completion, accuracy, and quality of all regulatory and submiss...
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...
Director Global Regulatory Affairs – Companion Diagnostics/In Vitro Diagnostics. Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, and compliant drug/diagnostic regulatory strategies and approaches acros...
Director, Regulatory Affairs Strategy. 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 mainten...
Associate Director, Regulatory Affairs UK. A new opportunity has arisen in the UK Regulatory Affairs Department, at the Associate Director level. Working with Global Regulatory Policy and other stakeholders to advocate for therapeutic areas/local positions on regulatory issues and shape the regulato...
Senior Director, Regulatory Affairs Strategy. 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 ...
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...
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 Senior Director, Regulatory Affairs will lead and formulate the regulatory affairs strategy for pharmaceutical products. Perform regulatory risk assessment and provide regulatory input to the CEO and executive team; provide regulatory strategy for new pharmaceutical developments. Research and ke...
This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). More Years of direct regulatory affairs experience, including US labeling expe...
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...
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...
More Years relevant pharmaceutical experience including experience within Regulatory Affairs. Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. ...
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 ...
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...
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...
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...
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 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...
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 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...
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...