Regulatory Affairs Specialist

Responsibilities: Oversee the day-to-day functions of the regulatory initiatives for Hassen Implants, Digital, and Biomaterial Solutions. Develop regulatory strategies for new, existing, and modified medical devices and other regulated products. Manage and submit 510(k) submissions and handle communications with the FDA, including pre-submissions....

Responsibilities: Oversee the day-to-day functions of the regulatory initiatives for Hassen Implants, Digital, and Biomaterial Solutions. Develop regulatory strategies for new, existing, and modified medical devices and other regulated products. Manage and submit 510(k) submissions and handle communications with the FDA, including pre-submissions....

Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports,...

Reporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects. **Responsibilities** - Prepare and/or coordinate and comply routine regulatory submissions and other...

The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...

The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...

Job DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...

Job DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...

Job DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...

Reporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. **Responsibilities** - Formulate regulatory strategies, with supervisor oversight, based on current...

Our client is seeking a high level Regulatory consultant specializing in Immunology. In this role, you will lead strategic regulatory efforts. In addition, act as Global Regulatory Lead, shape global expansion and clinical registration strategies. Responsibilities: •Devise global regulatory strategies, serve as an expert leader. •Craft & review accurate...

Our client is seeking a high level Regulatory consultant specializing in Immunology. In this role, you will lead strategic regulatory efforts. In addition, act as Global Regulatory Lead, shape global expansion and clinical registration strategies. Responsibilities: •Devise global regulatory strategies, serve as an expert leader. •Craft & review accurate...

Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as po Regulatory Affairs, Director, Oncology, Regulatory, Leadership, Strategy, Business Services

**Company Description** **Job Description** Key Responsibilities** - Responsible for providing regulatory strategy & support for global development. - Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project...

Job DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...

Job DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...

Job DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...

About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...

About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...

Job Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is...