- Lilly (Indianapolis, IN)
- …**Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative ... acceleration strategies. Identify and effectively communicate regulatory risks. + Lead Global Regulatory Team in the development of RSD(s) for assigned… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... development, regulatory , and registration strategies. + The Director, Global Regulatory Lead supporting programs within BeOne's Hematology Franchise,… more
- Takeda Pharmaceuticals (Boston, MA)
- …function on cross-functional Global Program Teams. The Senior Director also will lead discussions of regulatory strategy with senior leadership of the TAU ... opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific… more
- Takeda Pharmaceuticals (Boston, MA)
- …opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific ... my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... providing operational support for assigned programs. + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, ... approval of all submissions and associated documentation. + Provide expertise as the Global Regulatory Lead to Product Development Teams and regulatory … more
- Pfizer (Collegeville, PA)
- …**ROLE SUMMARY** This Director, Global Regulatory Sciences - Vaccines position is the Global Regulatory Lead and US Regional Regulatory Lead ... combination Influenza/COVID mRNA vaccine program and the US Regional Regulatory Lead for the COVID-19 mRNA vaccine...worldwide (Influenza/COVID-19) or the US FDA (COVID-19). At Pfizer Global Regulatory Sciences contribution is "end to… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global ... submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… more
- Sanofi Group (Morristown, 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...management of products. + May serve as a regional/local regulatory lead and point of contact with… more
- Merck (Austin, TX)
- …submission experience in IBD strongly preferred. **Primary Responsibilities** + Develop and lead global regulatory strategies to support multiple ... & International Regulatory Affairs with prior experience as a Global Regulatory Lead + Demonstrated scientific knowledge, writing ability, effective… more
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... strategies for the program(s) under your accountability. You will lead the regulatory strategy and initiatives for...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Leidos (Reston, VA)
- … regulatory compliance matters to include international anti-corruption compliance. The Lead Attorney for Global Regulatory Compliance will be ... role requires a strategic thinker with deep expertise in global regulatory laws and the ability to...on complex legal matters across multiple jurisdictions. Additionally, the Lead Attorney will oversee the enterprise risk management program… more
- Gilead Sciences, Inc. (Washington, DC)
- …to align development and regulatory path for combination products and devices. . ** Global Regulatory Excellence** Lead the development of global CMC ... together. **Job Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with… more
- Corteva Agriscience (Indianapolis, IN)
- …the correct implementation of Corteva product development processes. + Accountable to lead global regulatory teams supporting business objectives. Engages ... Headquarters in Indianapolis, IN. The Global Regulatory Leader (GRL) is accountable to lead regulatory teams to develop and implement global … more
- Lilly (Indianapolis, IN)
- …and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Provide coaching and oversight for ... of the US Business Unit, the Sr. Director will lead a team of regulatory personnel, providing...and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Regularly… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC ... and compliance while balancing business benefits and risks. + Lead and Manage Global Regulatory ...benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning,… more
- Takeda Pharmaceuticals (Boston, MA)
- …promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject ... in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review … more
- BeOne Medicines (Emeryville, CA)
- …and upgrades. + Perform impact analysis and prepare the organization to meet new global regulatory requirements. + Lead and participate in business process ... **General** **Description:** This position resides in the Global Regulatory Operations Strategy & Innovation...authoring standards, timelines, and tools. + Serve as APAC lead and SME for developing global electronic/paper… more
- Oura (San Francisco, CA)
- …compliance program, ensuring alignment with global best practices and regulatory expectations. + Lead anti-bribery and anti-corruption (ABAC) compliance, ... regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance: + Serve as the primary legal advisor on FDA, EU MDR,… more
Related Job Searches:
Director Global Regulatory Lead,
Global,
Global Regulatory,
Global Regulatory Lead Oncology,
Lead,
Regulatory