Proclinical is seeking an Associate Director, Global Regulatory Labeling Strategy for a growing global immunology-focused biotechnology company based in the Greater Boston, MA Area. Strong understandi...

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...

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...

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

The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives fo...

The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives fo...

Our client is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of its Global Regulatory Affairs organization. Associate Director, Global Regulatory Affair...

Our client is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of its Global Regulatory Affairs organization. Associate Director, Global Regulatory Affair...

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. BS/BA in Life Sciences in a relevant field required; adv...

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

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

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...

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. Regulatory Affairs Certified is a plus. Represent regula...

Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Represent regulatory affairs on assigned project teams a...

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...

The Director of Regulatory Affairs will oversee a team of regulatory specialists and collaborate closely with clients, internal teams, and external stakeholders to achieve regulatory compliance and fa...

Serve as primary regulatory liaison to commercial, medical affairs, legal, etc. Support budgeting and forecasting for function and Regulatory Affairs department. Minimum 10 years of relevant experienc...

Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Ensure global development plans will meet global regulatory requirements by ...

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...

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 ...

You will work closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional Regulatory Liaisons and cross-functional stakeholders to communicate a clear vision and provide st...

The responsibilities include providing US regulatory leadership and direction for Rocket’s gene therapy products, including developing long and short-term planning of regulatory projects that align wi...

The Director of Regulatory Affairs will oversee a team of regulatory specialists and collaborate closely with clients, internal teams, and external stakeholders to achieve regulatory compliance and fa...

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...

Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred). Genmab is looking for an experienced and passionate leader to...