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...

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...

Genmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global Regulatory Affairs organization. Evaluate regulatory risk and recommend mitigatio...

Genmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global Regulatory Affairs organization. Evaluate regulatory risk and recommend mitigatio...

More Years in regulatory affairs; experience in US regulatory affairs from IND through NDA/BLA required. This role will be accountable for ensuring consistent and transparent ways of working across th...

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. The Associate Director, Regulatory CMC, is responsible ...

The Executive Director, Global Regulatory Affairs Therapeutic Area Leader- GTAL provides strategic oversight and direction for regulatory activities on a global and/or regional scale across one or mor...

The Executive Director, Global Regulatory Affairs Therapeutic Area Leader- GTAL provides strategic oversight and direction for regulatory activities on a global and/or regional scale across one or mor...

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...

As a Senior Director of Regulatory Affairs, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obli...

This role will work collaboratively across various functions including Regulatory Affairs, Clinical Development, CMC, Clinical Pharmacology, Clinical Supply (CS), Medical Affairs/Medical Information, ...

This role will work collaboratively across various functions including Regulatory Affairs, Clinical Development, CMC, Clinical Pharmacology, Clinical Supply (CS), Medical Affairs/Medical Information, ...

As a Senior Director of Regulatory Affairs, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obli...

The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post approval research, including the devel...

The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Utilize regulatory expertise and knowledge of regulatory requirements and r...

Director Global Quality and Regulatory Compliance. Responsible for ensuring product meets all product claims specifications and regulatory requirements throughout the product lifecycle. Good understan...

The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Utilize regulatory expertise and knowledge of regulatory requirements and r...

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...

Director Global Quality and Regulatory Compliance. Regulatory compliance and / or quality assurance experience. Respond to regulatory agency inquiries.

Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Our client is currently seeking a Associate Director, Re...

The Executive Director, Global Regulatory Affairs Therapeutic Area Leader- GTAL provides strategic oversight and direction for regulatory activities on a global and/or regional scale across one or mor...

Director Global Quality and Regulatory Compliance. Regulatory compliance and / or quality assurance experience. Respond to regulatory agency inquiries.

Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Our client is currently seeking a Associate Director, Re...

The Executive Director, Global Regulatory Affairs Therapeutic Area Leader- GTAL provides strategic oversight and direction for regulatory activities on a global and/or regional scale across one or mor...

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...

Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. US Medical Device Regulatory Affairs experience. Ensure global development p...

Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. US Medical Device Regulatory Affairs experience. Resp...

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...

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...

Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice. The Global Labeling Director provides regulatory expertise and guidance for lab...

Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice. The Global Labeling Director provides regulatory expertise and guidance for lab...

The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products. Knowledge of pharmaceutical brand industry regulatory affairs d...

The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products. Knowledge of pharmaceutical brand industry regulatory affairs d...

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...

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...

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...