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 Reg...

More Years of direct regulatory affairs experience, including US labeling experience required. This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently pro...

Genmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global Regulatory Affairs organization. In this role, you will work in close collaborati...

Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements. The Associate Director, Regulatory CMC, is responsible ...

Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements. Supports the regulatory function on development teams p...

The Associate Director, Regulatory CMC, is responsible for contributing to/assisting with the development and implementation of global regulatory CMC strategies supporting investigational and marketed...

The Associate Director, Regulatory CMC, is responsible for contributing to/assisting with the development and implementation of global regulatory CMC strategies supporting investigational and marketed...

Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Broad knowledge of the p...

Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. Strong business acumen and the ability to see business drivers outside of regulatory affairs. The A...

RA Ad/ Promo provides strategic regulatory guidance Regulatory Affairs, Director, Advertising, Regulatory, Associate, Dance, Business Services. Regulatory Advertising and Promotion (RA Ad/ Promo) is a...

The Regulatory Affairs Associate will support the regulatory functions for a global medical device company. Provide regulatory guidance during the design and development phases of new medical devices,...

The Regulatory Affairs Associate will support the regulatory functions for a global medical device company. Prepare, compile, and submit regulatory documents to regulatory agencies (e. Monitor and ana...

The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide...

More Years of direct regulatory affairs experience, including US labeling experience required. This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently pro...

More Years of direct regulatory affairs experience, including US labeling experience required. This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently pro...

Our client is currently seeking a Associate Director, Regulatory Affairs Strategy. Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex...

Our client is currently seeking a Associate Director, Regulatory Affairs Strategy. Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex...

The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide...

The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide...

Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. Experience with developing regulatory strategies in c...

Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. Responsible for understanding the regulatory landscap...

As our project portfolio at Genmab continues to grow, we are expanding our team and seeking a Team Lead, Associate Director to join the Regulatory Affairs CMC (RA CMC) team. We offer an exciting and c...

The Regulatory Affairs Associate (Compliance Medical Auditor) supports the functions of the Compliance Program for ENT and Allergy Associates, LLP, (ENTA) to be compliant with Federal and State guidel...

The Regulatory Affairs Associate (Compliance Medical Auditor) supports the functions of the Compliance Program for ENT and Allergy Associates, LLP, (ENTA) to be compliant with Federal and State guidel...

Experience (years/area): Minimum of 15 years of executive leadership experience in regulatory affairs, regulatory compliance, or pharmaceutical regulatory strategy, with a proven track record in the g...

Experience (years/area): Minimum of 15 years of executive leadership experience in regulatory affairs, regulatory compliance, or pharmaceutical regulatory strategy, with a proven track record in the g...

The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products. Act as a regulatory contact with Regulatory Authorities for ass...

Lead and manage all regulatory affairs-related activities for products o Serve as the regulatory liaison for FDA submissions and communicationso Lead, manage, review, and submit documents eCTD submiss...

Lead and manage all regulatory affairs-related activities for products o Serve as the regulatory liaison for FDA submissions and communicationso Lead, manage, review, and submit documents eCTD submiss...

The Regulatory Affairs Associate will support the regulatory functions for a global medical device company. Regulatory Submissions: Assist in preparing and submitting regulatory filings for medical de...

The Regulatory Affairs Associate will support the regulatory functions for a global medical device company. Regulatory Submissions: Assist in preparing and submitting regulatory filings for medical de...

RA Ad/ Promo provides strategic regulatory guidance Regulatory Affairs, Director, Advertising, Regulatory, Associate, Dance, Business Services. Regulatory Advertising and Promotion (RA Ad/ Promo) is a...

Responsibilities:Provides strategic and operational leadership in advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA gu...

The Regulatory Affairs Associate (Compliance Medical Auditor) supports. Each ENT and Allergy Associates clinical location provides access to a full complement of services, including General Adult and ...

Each ENT and Allergy Associates clinical location provides access to a full complement of services, including General Adult and Pediatric ENT, Voice and Swallowing, Facial Plastics and Reconstructive ...

Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives. Experience with clinical trial assays (CTA) in drug clinical trials in communicating betw...

The Regulatory Associate will report to the Senior Manager, Regulatory Affairs and, under the direction and guidance of the Associate Vice President, will help to ensure regulatory compliance of Prest...

Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. Works closely with the Regulator...

Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Dem...

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...