- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory lead you will also be responsible for ensuring that global regulatory strategy is integrated into Pharmaceutical Development & Manufacturing ... CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position… more
- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as a Director, Pharmaceutical Sciences Program Leadership where you will be responsible for implementing ... Pharmaceutical Sciences' Research to Development operating model on a...(US, JP, EU). + Deliver excellence in leadership, CMC strategy development, and implementation of the strategy … more
- Takeda Pharmaceuticals (Boston, MA)
- …technical expertise but across Takeda competencies. + Independently leads development of strategy and plans for multiple, complex programs + Regularly leads and ... influences functional/divisional strategy , operations and innovation + Functional thought leader and...Acumen** **:** + Provides scientific leadership and innovation in pharmaceutical research and development. Builds teams across functions and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …& Responsibilities** Regulatory Expertise: The Fellow will develop basic regulatory strategy expertise/knowledge in one or more therapeutic areas. Interact ... and RA sub-team, provide leadership in the development and implementation of US regulatory strategy within a global development context. + Assess US strategic… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Lundbeck (Deerfield, IL)
- Senior Manager Regulatory Strategy - Remote Opportunity Requisition ID: 5804 Location: Deerfield, IL, US Do you want to join a team where the mission is ... Preferably East Coast or Midwest.** **SUMMARY:** The Senior Manager, Regulatory Strategy (US RA): supports the creation...+ Accredited Bachelor's Degree + 7+ years within the pharmaceutical and/or biotech industry or for a consulting company… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. Gain endorsement from ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… more
- Fujifilm (Thousand Oaks, CA)
- …our company, our community, and the world at large. The Director, Pharmaceutical Quality Systemswill lead the Quality Systems, Validation, Compliance and Supplier ... system processes. **External US** **Summary of Position:** The Director, Pharmaceutical Quality Systemswill lead the Quality Systems, Validation, Compliance and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development… more
- Procter & Gamble (Greensboro, NC)
- …to lead a team responsible for end-to-end quality assurance in our pharmaceutical & dietary supplement manufacturing facility in Greensboro, NC. This manufacturing ... and initiative delivery at P&G dietary supplement and OTC pharmaceutical manufacturing site. + Own one product form (liquid,...Ideal Candidate + Has a passion for leading quality strategy and teams in a fast-paced environment + Is… more
- Spark Therapeutics Inc. (Philadelphia, PA)
- Regulatory Strategy Lead **Date:** Oct 11, 2024 **Location:** Philadelphia, PA, US, 19104 **Company:** Spark Therapeutics Join the Spark Team We were born of ... We don't follow footsteps. We create the path. **Primary Duties** The Regulatory Strategy Leadwill support developmental and post-approval projects as assigned.… more
- AbbVie (North Chicago, IL)
- …Affairs Strategy roles (US and Canada) are: 1. Responsible for providing regulatory strategy & support for global development. 2. Responsible for supporting ... Area Head with the development & execution of the regulatory strategy . 7. Serve as HA liaison...R&D, or Industry-related experience is required. 2-3 years in pharmaceutical regulatory activities is preferred. + Demonstrates… more
- Boehringer Ingelheim (North Brunswick, NJ)
- …etc. + Provide technical leadership and guidance for questions received from Regulatory Authorities in various regulatory processes, eg geographical expansion of ... existing products, post approval changes on existing registrations. + Lead strategy development and deployment of technical solutions for process optimization/… more
- AbbVie (San Francisco, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Global Regulatory Strategy US & Canada is responsible for the development ... Lead (GRL)), in the development and execution of the regulatory strategy . Assigned matters may have an...or Industry-related experience. + Preferred Experience: 2-3 years in pharmaceutical regulatory activities + Skill Set: Proven… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs, NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to 30% ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across… more
- AbbVie (Irvine, CA)
- …and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for ... regulatory dossiers. + May lead the Labeling Regulatory Strategy Team (LRST), and serve as...management skills. + Preferred Experience: 7-10+ years' experience in pharmaceutical regulatory activities, with experience as lead… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical ... Regulatory filings and provide regulatory leadership on...you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Global Regulatory Strategy Infrastructure Intern Overview Envision spending your ... in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie's Experiential...is a reality for AbbVie's Experiential Interns. The Global Regulatory Strategy Infrastructure Intern will support the… more
- Amgen (Los Angeles, CA)
- … activities to ensure effective FDA interactions consistent with the Global Regulatory strategy -includes contingency regulatory planning/risk assessment + ... regulatory documents and meetings in accordance with GRT strategy (eg, responses to regulatory agency questions)...Qualifications:** Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development Or Master's… more
- Takeda Pharmaceuticals (Boston, MA)
- …Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a ... and complexity of technical knowledge) + Comprehensive understanding of the pharmaceutical industry, R&D, and regulatory affairs + Experience managing… more