- 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...management of our products globally. + Collaborate with Government Affairs and Commercial to advance important regulatory … 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
- BD (Becton, Dickinson and Company) (Durham, NC)
- …us. **Summary:** Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) Regulatory Affairs Manager, the Senior Specialist, Regulatory ... expertise to MMS-PA platform. This individual conducts the regulatory affairs activities within the MMS-PA platform....new product development programs, serving as a Core Team advisor and champion for MMS-PA's Global Product… 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
- M&T Bank (Clanton, AL)
- …Director to engage other Risk Departments, Internal Audit, Legal and/or Regulatory Affairs regarding interrelated risk issues impacting fiduciary, operational, ... regulatory reporting. **Scope of Responsibilities:** The Senior Compliance Advisor works under general supervision of the respective Senior Compliance Manager… more
- AbbVie (San Juan, PR)
- …the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as ... with the scientific review, development, approval, execution and communication of affiliate/area/ global medical affairs sponsored or supported clinical research… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as… more
- Aegon Asset Management (Cedar Rapids, IA)
- Job Family Regulatory Compliance About Us At Transamerica, hard work, innovative thinking, and personal accountability are qualities we honor and reward. We ... General Counsel, Risk, Internal Audit, Strategy and Development, and Corporate Affairs , which covers Communications, Brand, and Government and Policy Affairs… more
- Lilly (Indianapolis, IN)
- …cross-functional teams, including Product Research and Development, quality assurance, and regulatory affairs , to enable the commercialization of the product ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Lilly (Indianapolis, IN)
- …Medicines, Therapeutic Area Teams, Drug Disposition, Bioproduct Development and Regulatory Affairs . **KEY OBJECTIVES/DELIVERABLES:** + Lead research efforts ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Corteva Agriscience (Indianapolis, IN)
- … Team Leader or designee + Serve as a key advisor on country regulatory matters to the Global Regulatory Leader and their respective networks + ... regulatory strategy development, communication, and implementation with the Global Regulatory Leaders and Global /Regional...+ Highly preferred - Experience in US crop protection regulatory affairs and FIFRA pesticide law. +… more
- J&J Family of Companies (Santa Clara, CA)
- … Regulatory Compliance in Shockwave worldwide. Partners with leaders in R&D, Regulatory Affairs , Quality, Legal, Supply Chain, Clinical and Johnson & Johnson ... Johnson & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical** to join our team...to our business partners, including compliance data & current global health authority trends that enable the organization can… more
- Applied Materials (Austin, TX)
- …timelines, and resource allocation. . Stay up to date with evolving global regulatory requirements and industry standards, ensuring compliance across all ... closely with cross-functional teams, including product development, engineering, legal, and regulatory affairs , to ensure compliance requirements are integrated… more
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