- Lilly (Indianapolis, IN)
- …who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... + Development of regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC teams to… more
- Lilly (Indianapolis, IN)
- …Deep technical knowledge of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product ... regulatory strategy to ensure alignment with current and evolving global regulatory expectations + Provide regulatory guidance to allow CMC development… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within ... Gilead's Global Regulatory Affairs organization and acts as a...of ex-U.S. labeling. You will act as a key advisor to cross-functional partners, stakeholders, and teams. You will… more
- AbbVie (Irvine, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director of Regulatory Affairs - Soft Tissue Fillers supports regulatory ... global submissions to support new registrations. As Global regulatory lead (GRL), directs and supports... interactions with R&D, Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory… more
- Ascendis Pharma (Princeton, NJ)
- …Commercial, Medical Affairs , and Leadership team to develop and implement the Global Regulatory Affairs plan across products, design and implement launch ... to join a rapidly growing innovative company. The Director, Global Regulatory Strategy and Policy Advisor...Minimum 10 years of documented professional experience at a Regulatory Affairs leadership position within the pharmaceutical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... in a professional and timely manner. Acts as an advisor and liaison to senior management. + As a...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Stryker (Philadelphia, PA)
- We are currently seeking a **Principal Regulatory Affairs Specialist,** ( **Pharmaceutical Products** ) to join our **Medical** Division. This is a Hybrid role ... Cary, Illinois. **What you will do** As the **Principal Regulatory Affairs Specialist,** you will play a...will play a pivotal role in shaping and executing global regulatory strategies for drug development and… more
- Actalent (St. Louis, MO)
- …in other regions and participates in global regulatory teams. Skills Regulatory documents, Regulatory affairs , Regulatory , Regulatory ... Description Major Responsibilities/Accountabilities: * Regional Regulatory Affairs contact / facilitator for...advice, guidance, support, and education. * Interfaces with the global HERA Product Regulatory Managers for fertilizer… more
- S&P Global (New York, NY)
- …internal use):** 11 We are seeking a dedicated professional to support Ratings' Regulatory Affairs team in various activities, including: + Monitoring updates to ... internal control assessment process for the Ratings Legal & Regulatory Affairs function, as well as the...(This section is only applicable to US candidates) S&P Global states that the anticipated base salary range for… more
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