CMC 2 Regulatory affairs

The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at .Associate Director, Global Regulatory Affairs CMC page is loaded Associate Director, Global Regulatory Affairs CMC Apply locations Copenhagen time type Full time posted on Posted Yesterday job...

Overview: Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on womens health. Our first Research and Development facility in the US is located...

Summary This position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with...

Assistant Director/Director of Regulatory Affairs Location:Summit, NJ 5 days on site Step into the realm of regulatory strategy and compliance as the Assistant Director/Director of Regulatory Affairs. This pivotal role is designed for a visionary who thrives on regulatory frameworks and is passionate about steering biologic products through the complex...

Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can...

Regulatory Affairs Manager Opening Zing Recruiting, in partnership with an established flavor and fragrance manufacturer is on the search for a Regulatory Affairs Manager to join their team! This is an exciting opportunity for candidates skilled within the flavors manufacturing industry, as this will support their food and beverage team. This is a remote...

Regulatory Affairs Project Manager page is loaded Regulatory Affairs Project Manager Apply locations Somerset, NJ time type Full time posted on Posted Yesterday job requisition id 0083859 Regulatory Affairs Project Manager Position Summary Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager . The Regulatory Affairs Project Manager is...

Summary: U.S. Branded & Generic Product Portfolios The Regulatory Affairs Labeling Senior Associate is a key member of the Regulatory Affairs Labeling team and will report directly to the Regulatory Affairs Labeling Director. The Regulatory Labeling Senior Associate will be responsible for the development/revision of labeling content along with the review...

Associate Director, CMC Lead in Basking Ridge at Daiichi Sankyo Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and...

Associate Director, US Regulatory Affairs Strategy page is loaded Associate Director, US Regulatory Affairs Strategy Apply remote type Hybrid Work Arrangement locations Basking Ridge, NJ Remote by Design Home Office time type Full time posted on Posted 2 Days Ago job requisition id R3352 Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo...

We are currently partnered with a growing biopharmaceutical company in need of a Manager/Sr. Manager of Regulatory Affairs Strategy to join their team. This company currently has an FDA approved product on the market with a robust pipeline in Rare Disease, Hematology and Neuroscience.This role is responsible for developing, implementing, and leading...

We are currently partnered with a growing biopharmaceutical company in need of a Manager/Sr. Manager of Regulatory Affairs Strategy to join their team. This company currently has an FDA approved product on the market with a robust pipeline in Rare Disease, Hematology and Neuroscience. This role is responsible for developing, implementing, and leading...

About the OpportunityOur client is a growing biopharmaceutical company in need of a Sr. Manager/Associate Director of Regulatory Affairs Strategy to join their team. This role is responsible for developing, implementing, and leading short/long term global regulatory strategies that support the success of their pharmaceutical products.The annual base salary...

Objective The Director, CMC Operations responsible for technically designing, managing, and executing a plan for the use of alpha emitting Pb-203 & Pb-212 radiopharmaceuticals and the manufacturing of drug candidates supporting clinical trials and readiness for commercial deployment. S/he will act as a champion and advocate for a strategic vision in...

Responsibilities: Develop global regulatory strategy for Oncology products in development and through life cycle management considering all relevant guidance, commercial needs, and company objectives. Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial...

Meet's partenered with a global pharmaceutical manufacturing company on an exciting new search for a Director, US Regulatory StrategyYou'll be responsible for creating and implementing regulatory strategies, directing and implementing the preparation of US Regulatory submissions, meeting deadlines for regulatory agencies, shortening the review process, and...

Medical Affairs Consultant The Medical Affairs Consultant tasks include: Collaborating with Medical Affairs colleagues and external vendors to execute asset strategy and tactical plans with appropriate use of resources and according to developed timelines Providing high quality scientific/clinical input and review of medical content of promotional and...

Job Description - Communications & Community Affairs Manager (00030261) Communications & Community Affairs Manager - 00030261 Our greatest asset has been and will continue to be our people. We are looking for an experienced and motivated individual to fill the position of Manager, Communications & Community Affairs based in New Jersey. The Manager will drive...

Job DetailsJob Location New Jersey Hamilton - Hamilton, NJ Position Type Full Time Job Shift Full-time DescriptionPRIMARY PURPOSE (Summary of major reasons this job exists) The New Jersey Energy Efficiency Outreach Coordinator will be responsible for coordinating outreach efforts to promote residential energy efficiency programs. This includes organizing...

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). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position...