Director, US Regulatory Affairs - Advertising and Promotion. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and gu...

The Director, Global Regulatory Labeling Strategy will:. Labeling working group (LWG) - Cross functional team which members are identified in function of topics among Development team, Project team, P...

The Director, Global Regulatory Labeling Strategy will:. Labeling working group (LWG) - Cross functional team which members are identified in function of topics among Development team, Project team, P...

Extensive hands-on experience in the development of key regulatory submissions, including NDAs, BLAs, MAAs, and INDs, as well as interacting with regulatory authorities and supporting site/sponsor reg...

Serves as a liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Regulatory Affairs Certified is a plus. BS/BA in Life Sciences i...

Extensive hands-on experience in the development of key regulatory submissions, including NDAs, BLAs, MAAs, and INDs, as well as interacting with regulatory authorities and supporting site/sponsor reg...

BS/BA in Life Sciences in a relevant field required; advanced degree strongly preferred (PharmD, MD, PhD) with 7-10 years of regulatory experience in the branded biotech/pharma industry supporting reg...

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...

Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Regulatory Affairs Certified is a plus. BS/BA in Life Sc...

Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. BS/BA in Life Sciences in a relevant field required; adv...

Associate Director, CMC Regulatory Affairs. MannKind Corporation has an opening for an Associate Director, CMC Regulatory Affairs in Danbury, CT. At least 5 years of experience working with analysis a...

Associate Director, CMC Regulatory Affairs. MannKind Corporation has an opening for an Associate Director, CMC Regulatory Affairs in Danbury, CT. Assist with development of documents submitted to heal...

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. Utilize regulatory expertise and knowledge of regulatory requirements and r...

We are seeking an experienced and highly motivated Associate Director, Regulatory Affairs to support our expanding portfolio in the oncology area. Minimum of 5 years of regulatory affairs experience i...

We are seeking an experienced and highly motivated Associate Director, Regulatory Affairs to support our expanding portfolio in the oncology area. Minimum of 5 years of regulatory affairs experience i...

Support the Global Therapeutic Area Lead (GTAL), Regulatory Affairs (Senior Director) in developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within specif...

Support the Global Therapeutic Area Lead (GTAL), Regulatory Affairs (Senior Director) in developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within specif...

Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA's Office of Prescri...

Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. BS/BA in Life Sciences in a relevant field required; adv...

Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. BS/BA in Life Sciences in a relevant field required; adv...

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. Sig...

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 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 Director of Regulatory Affairs is a senior leadership position within our consulting firm, responsible for providing strategic guidance and expert knowledge in the field of regulatory affairs to 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...

The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug d...

Work closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned. SPARC is seeking a Senior Director, Global Regulatory ...

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 i...

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-clini...

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. Provides strategic ...

Provides strategic regulatory direction including developing the US regulatory plan, advising on US regulatory requirements for development plans, study designs and marketing approval, conducting risk...

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...

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...

Demonstrates in-depth knowledge of current trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects. Significant experie...

Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional t...

Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred). Act as the US/Global Regulatory Leader (GRL) for assigned pro...