- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Director , Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive ... regulatory strategies to ensure compliance with global health authorities....of trends and metrics across the development pipeline. The Senior Director will guide and support the… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages ... regulatory strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous improvement in … more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …their aspirations. Join Kite and help create more tomorrows. **Job Description** The Senior Director , Regulatory Affairs , Advertising and Promotion ... Santa Monica, CA, and will report to an Executive Director in Regulatory Affairs . **Responsibilities:**...ability to work autonomously with minimal oversight from a senior regulatory affairs professional +… more
- ADM (Chicago, IL)
- **96226BR** **Job Title:** Senior Director of Regulatory & Scientific Affairs , Health & Wellness **Department/Function:** Research & Development **Job ... Description:** ** Senior Director , Regulatory and Scientific Affairs , Health & Wellness - Chicago, IL; Decatur, IL; Kennesaw, GA; or Erlanger, KY**… more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area ... as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to...devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual ... in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …some of the most challenging global health issues. The Director of Regulatory Affairs reports directly to the Senior Director of Regulatory ... Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of... regulatory compliance + Problem tackle and escalate regulatory and compliance issues to senior management… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Mount Sinai Health System (New York, NY)
- …Director , Regulatory Compliance- Mount Sinai Health System** The Senior Director for Regulatory Affairs is responsible for assisting the Vice ... President, Quality and Regulatory Affairs , MSHS, in maintaining a state of regulatory compliance across the MSHS, through proactive tracking, communication,… more