- Actalent (Gaithersburg, MD)
- …delivery systems , and recommending suitable actions. Responsibilities: + Global Strategy Development : Craft and implement global regulatory strategies for ... Regulatory Affairs will spearhead the creation and execution of a unified regulatory strategy , encompassing regulatory operations, to ensure and sustain… more
- Medtronic (Los Angeles, CA)
- …**A Day in the Life** Principal Regulatory Affairs Specialist - Global Regulatory Strategy and Advocacy position sits in the regulatory organization ... helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in...clinical study design, etc.) to assure alignment with global regulatory strategy . + Follow all work/quality procedures… more
- AbbVie (Irvine, CA)
- …development, communication, and execution of US regulatory strategic plans to Global Regulatory Lead (GRL) and project team. Plans and prepares (or oversees) ... filing strategy , with minimal supervision. Provides regulatory strategy and guidance to global product...of submissions to FDA as a primary contact and lead meetings with FDA. + + + Essential Skills… more
- Citigroup (Queens, NY)
- …projects as well as implementation of new reporting systems . **Responsibilities:** + Lead the review of multiple areas of regulatory filings such as FR ... (USRRI) to strengthen controls and improve report accuracy. + Lead /participate in regulatory exams, internal audits and...to align teams and resources to fit the overall strategy . + Highly motivated and goal-oriented with ability to… more
- J&J Family of Companies (Horsham, PA)
- Lead , Specialty Compliance Policy and Regulatory ...collaboration with leadership to create, execute and align the strategy for roll out of new systems ... Operations - 2406212913W **Description** Johnson & Johnson is recruiting for a Lead , Specialty Compliance Policy and Regulatory Operations within the Health Care… more
- Citigroup (New York, NY)
- Regulatory Execution Senior Lead / Hybrid About the role: The Regulatory Execution team is part of ERM Data & Technology Governance function which oversees ... adoption across the enterprise and relevant businesses / functions / regions + Lead execution of Regulatory and Internal Audit Corrective Action Plans +… more
- Citigroup (Tampa, FL)
- Regulatory Execution Senior Lead / Hybrid **About the role:** The Regulatory Execution team is part of ERM Data & Technology Governance function which ... adoption across the enterprise and relevant businesses / functions / regions * Lead execution of Regulatory and Internal Audit Corrective Action Plans *… more
- Novo Nordisk (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an insights-driven HCP marketing ... vision and message. Relationships Reports to the Integrated TA Strategy Lead . Responsible for providing interface with...for launch, development and/or life cycle activities + Health Systems strategy : Collaborates with medical affairs and… more
- Citigroup (Tampa, FL)
- … regulatory examination planning period through formal management response to regulatory supervisory letters. + Establish and lead formal communication ... priorities as applied to Citibank and Citigroup. + Analyze regulatory reports, Management Information Systems , and make...senior executives. + Capability to contribute to both the strategy and execution of an associated operational plan +… more
- Kohler Co. (Palo Alto, CA)
- **QA Lead Software and Regulatory - Kohler Ventures** _Work Mode: Hybrid_ **Location:** Hybrid 3 days/onsite in Palo Alto, CA **Opportunity** Kohler Ventures is ... Our mission is to build new digital businesses that empower consumers to lead healthier lives. We explore how familiar experiences can be enhanced and innovations… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the development process to ensure submission acceptance and approval + Manages the device regulatory strategy of high quality and compliant regulatory device ... Takeda R&D functions to provide an effective and aligned regulatory device strategy and submission approach globally,...solutions. + Ability to identify areas for process and systems innovation and implement change that will enhance the… more
- Citigroup (Irving, TX)
- The Data Transformation Regulatory Commitment Lead is a leadership position in the Data Product and Program Management organization within Citi's Chief Data ... the data operating model and executing the strategic and regulatory priorities for the firm. The CDO defines and...governance and management. This role is a senior transformation lead accountable for oversight and program management of a… more
- City National Bank (Newark, DE)
- ** STRATEGY & TRANSFORMATION LEAD - BIS** **WHAT IS THE OPPORTUNITY?** This leadership role drives the delivery of large scale, enterprise-wide initiatives and ... in managing and resolving key initiatives or projects that are critical to strategy success, including addressing risk, regulatory requirements, and blockers to … more
- Lilly (Indianapolis, IN)
- …internal quality systems . + Own relationship and interaction strategy with US and Canada regulatory authorities. + ... Purpose: The purpose of the Senior Director/Executive Director, Global Regulatory Affairs, Global Regulatory Lead ...is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local… more
- Amgen (Washington, DC)
- …guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA ... Operations Team, Global Regulatory Team and is responsible for communicating the regulatory strategy , risks and issues to Regulatory and Operations… more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... expertise to contribute to the definition of the global regulatory strategy , to enable and drive the...management of products. + May serve as a regional/local regulatory lead and point of contact with… more
- Sanofi Group (Waltham, MA)
- …of global Health Authorities interaction strategy in collaboration with the regulatory team members, attends and may lead Health Authorities meetings, and ... adults. Our team is responsible to develop and execute regulatory strategy for this new asset to...the Flu/Respiratory Syncytial Virus Franchise, reporting to the Global Regulatory Lead (GRL). We are an innovative… more
- Medtronic (Los Angeles, CA)
- …standard operating procedures, policies, work instructions, and user guides, as needed + Lead training on Regulatory Affairs systems and procedures, ... Bachelor's Degree with 2 years of medical device experience with work experience in regulatory affairs/ regulatory operations or quality systems + Or advanced… more
- Takeda Pharmaceuticals (Columbus, OH)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure ... you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and...goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and… more
- AbbVie (Florham Park, NJ)
- …assigned programs, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. ... clinical development. Coordinates and participates as the DS study owner in regulatory inspections and internal quality audits + Participates in oversight of vendors… more