- Ascendis Pharma (Palo Alto, CA)
- …Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area head for ... as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to...regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory … more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory ... Externally, the individual will interface with business partners regarding global development, regulatory , and registration strategies. + The Director , Global … more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Director , Regulatory Affairs will be responsible for developing and implementing global ... drug -device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing… more
- BeOne Medicines (San Mateo, CA)
- …to negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals ... **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… more
- Sumitomo Pharma (Sacramento, CA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Director , Regulatory Advertising & Promotion** . The Director is ... in the US. He/she will primarily function as the Regulatory reviewer for assigned products. This position is responsible...Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA. + Serve as internal… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of...will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Gilead Sciences, Inc. (Foster City, CA)
- … drug labeling. + Significant experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, ... Strong track record of successes working and negotiating with regulatory authorities. + Global prescription drug label...negotiating with regulatory authorities. + Global prescription drug label experience, US, EU, and potentially more. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …BA/BS with 10+ years' relevant experience. + 4+ years' experience in prescription drug labeling. + Significant regulatory experience in the biopharma industry is ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global … more
- Gilead Sciences, Inc. (Foster City, CA)
- …illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH requirements, ... and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively collaborates… more