- Beckman Coulter Diagnostics (Brea, CA)
- …Device Regulation (IVDR) as well as all other applicable global regulatory requirements.Maintain oversight, tracking, metric reporting and escalation of issues while ... and requests for information to FDA, MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher Business System (DBS) tools to drive compliance, effective… more
- Bristol Myers Squibb (Brisbane, CA)
- …. **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... pharmaceutical products across therapeutic areas + Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global… more
- Synchrony (Costa Mesa, CA)
- Job Description: **Role Summary/Purpose:** The VP, Controllership- Regulatory Reporting Leader is responsible for leading controllership efforts to prepare required ... FR Y-9LP, FR Y-11, FR Y-14Q and FR Y-15. You will lead regulatory reporting strategy, driving process improvement and automation efforts, including use of available… more
- Lilly (San Francisco, CA)
- …for people around the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and ... implement innovative global regulatory strategies for product(s) in the assigned therapeutic area....decision maker for the development & execution of global regulatory strategies from portfolio entry to end of life… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …to address some of the most challenging global health issues. The Director of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs. ... Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product...+ Lead and develop direct report associates to ensure regulatory compliance + Problem tackle and escalate regulatory… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) works with ... external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory ... This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global clinical… more
- Grifols Shared Services North America, Inc (Bakersfield, CA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to… more
- US Bank (Glendora, CA)
- …providers for mutual funds, exchange-traded funds (ETFs) and closed-end funds. The Regulatory Administration Paralegal position is part of the Regulatory ... Act of 1933, and regulated by the SEC. Each Regulatory Administration Paralegal is a key point of direct...in drafting and filing registration statements with the SEC. Regulatory Administration Paralegals work with our team of GFS… more
- Abbott (Santa Clara, CA)
- …in Santa Clara, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve Repair** . This new ... team member is responsible for the management and leadership of Regulatory Affairs activities for the Transcatheter Mitral and Tricuspid Heart Valve Repair… more
