- 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
- 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
- American Institutes for Research (Rockville, MD)
- …is seeking a confident, self-motivated, and creative **Medication and Pharmaceutical Policy Analyst** to join ourHealth (https://www.air.org/our-work/health) team to ... quality initiatives. Ideally, the candidate will have experience with pharmaceutical care in a clinical or retail setting. The...beyond legal compliance to its full integration in our strategy , operations, and work environment. At AIR, we define… 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
- 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
- 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
- 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
- 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
- Taiho Oncology (Princeton, NJ)
- …two clinical development programs as Regulatory Lead (RL), responsible for regulatory strategy and execution activities including IND/CTA, NDA/MAA filing in ... Associate Director, Regulatory Affairs Strategy Princeton, NJ, USA...Technical and scientific expertise in a discipline related to pharmaceutical development. Knowledge, Skills, and Abilities: + Ten years… 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)
- …team advancing Regeneron's vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs. The incumbent will ... to interact with senior managers in the company on regulatory strategies for product development. This management position in...or MD. + A minimum of 15 years of pharmaceutical industry or related experience, at least 5 of… 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
- Sumitomo Pharma (Columbus, OH)
- …This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...to contribute to the development and writing of a regulatory strategy document + Ability to learn… more
- Sumitomo Pharma (Columbus, OH)
- … Regulatory Leader (RRL) and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...to contribute to the development and writing of a regulatory strategy document in coordination with clinical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy + Guide the team to define and drive strategy ... in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (eg, technical regulatory strategy documents, storyboards, risk… more
- Amgen (Washington, DC)
- … 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